FDA Registration Active 🇹🇷 Türkiye

Bone Level O-Ring Abutment BORA40

Reg #: 3026026493 · FEI: 3026026493 · Expires 2025
Products
2
Proprietary Names
297
Establishment Types
1
Classifications
2

Registration Details

Registration Name
AGS MEDIKAL URUNLERI ITH. IHR. TIC. A.S.
Registration Number
3026026493
FEI Number
3026026493
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Kucukcamlica Mh. Ucpinarlar Cd., No:106, Ic Kapi No:4 Uskudar
City
Istanbul
Country
TR

Regulatory Submissions

510(k) Number
K160221

Owner / Operator

Firm Name
AGS Medikal Urunleri Ith. Ihr. Tic. A.S.
Operator Number
10087147
Address
Kucukcamlica Mh. Ucpinarlar Cd., No:106 Ic Kapi No:4, Uskudar
City
Istanbul
State
TR-34
Postal Code
34696
Country
TR
Correspondent
Bige Varlier

US Agent

Business Name
CardioMed Device Consultants, LLC
Contact Name
H. Semih Oktay
Address
1783 Forest Drive, #254 1783 Forest Drive, #254 Annapolis, MD 21401
City
Annapolis
State
MD
ZIP
21401
Country
US
Phone
410 2712088

Products

Device Name Product Code
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE

Proprietary Names

Bone Level O-Ring Abutment BORA40 Bone Level Impression Coping Pick-up Long BICP55L Tapered Drill TD3708, TD3710, TD3712, TD3714, TD4308, TD4310, TD4312 Octa Abutment Driver Long OADL Bone Level Healing Abutment BHA4530 Hex Driver for Ratchet Extra Long 1.2HDRXL Tissue Level Couple Abutment Wide TCAW30 Bone Level Angled Abutment BAA65152 Bar Clip Pink IBClip-P Bone Level Mini Solid Abutment BMSA3710 Surgical Guide Spoon Narrow/ Narrowly SGSpNNLY Bone Level Couple Abutment H7 BCA45207 Surgical Guide Bone Mill Narrow SGBMN Bone Level Solid Abutment BSA4530 Surgical Guide Tissue Punch Wide SGTPW Bone Level Mini Digital Analog BMFDLA Bone Level Mini Octa Abutment BMOA40 Surgical Guide Tapered Drill SGTD4808, SGTD4810, SGTD4812, SGTD4814 Bone Level Abutment Screw BMUASS Solid Abutment Driver SAD Bone Level Wide Fixture Hybrid RBM BWFHR5508 Drill Extension D/E Surgical Guide Tissue Punch Narrow SGTPN Bone Level Agressor Surgical Guide Kit BASGK Bone Level Mini Implant Hand Piece Drivers BMFDMS Bone Level Solid Abutment BSA4520 Tissue Level Scan Body TSB Bone Level Implant Ratchet Drivers BFDRL Bone Level Mini Impression Coping Transfer L BMICT37L O-Ring Retainer(red&black ring and metal cap) ORR Tissue Level Fixture Large Lab-Analog TFLLA Tissue Level Implant Ratchet Drivers TFDRL Tissue Level Hybrid Fixture TFHR4308 Locator Abutment Driver LAD Surgical Guide Mini Driver Ratchet Narrow Long SGMDRNL Bone Level Mini Fixture Straight RBM BMFSR3310 Bone Level Angled Abutment BAA65252 Bone Level Mini Healing Abutment BMHA3770 Bone Level Mini O-Ring Abutment BMORA05 Bone Level Couple Abutment H7 BCA45107 Tissue Level Solid Abutment Large Lab-Analog TSALLA70 Octa Abutment Titanium Cylinder OATICy Bone Level Mini Abutment Screw BMSAS Bone Level Mini Angled Abutment BMAA37154 Bone Level Impression Coping Transfer BIP45 Surgical Guide Tissue Punch Narrowly SGTPNLY Bone Level Impression Coping Pick-up Long BICP65L Octa Abutment Plastic Cylinder Non-Octa OAPICyN Bone Level Solid Abutment Lab-Analog BSALA55 Surgical Guide Mini Driver Ratchet Narrowly Short SGMDRNLyS Bone Level Implant Ratchet Drivers BFDRS Bone Level Implant Hand Piece Drivers BFDMS Bone Level Mini Solid Abutment BMSA3750 Bone Level Healing Abutment BHA6550 Octa Abutment Oclusal Screw OAS Tissue Level Wide Hybrid Fixture TWFHR5510 Bone Level Mini Couple Abutment H7 BMCA37207 Bone Level Fixture Hybrid RBM BFHR4810 Tissue Level Couple Abutment TCA40 Bone Level Solid Abutment BSA6530 Bone Level Impression Coping Pick-up Short BICP55S Octa Abutment Healing Cap OAHCap Bone Level Octa Abutment BOA50 Bone Level Mini Angled Abutment BMAA37152 O-Ring Retainer ORRc Bone Level Angled Abutment BAA65154 Tissue Level Solid Abutment Lab-Analog TSALA70 Bone Level Angled Abutment BAA55154 Tissue Level Implant Hand Piece Drivers TFDMS O-Ring Retainer ORRo Tissue Level Couple Abutment TCA10 Key for Parellelometer TFIC Tissue Level Closing Screw Wide TCLSW Bone Level Couple Abutment H7 BCA45407 Bone Level Solid Abutment BSA5540 Tissue Level Solid Abutment Large Lab-Analog TSALLA40 Tissue Level Hybrid Fixture TFHR3710 Bone Level Solid Abutment Impression Cap BSAICap55 Tissue Level Solid Abutment Lab-Analog TSALA40 Hex Driver Hand Piece Short 1.2HDMS Bone Level Octa Abutment BOA10 Bone Level Wide Fixture Hybrid RBM BWFHR5510 Tissue Level Couple Abutment Wide TCAW40 O-Ring Retainer 350 gr ORRO-g Bone Level Fixture Lab-Analog BFLA Bone Level Angled Abutment BAA45152 Tissue Level Solid Abutment TSA40 Bone Level Mini Solid Abutment BMSA3740 Bone Level Solid Abutment Impression Cap BSAICap45 Hex Driver for Ratchet Short 1.2HDRS Bone Level Fixture Hybrid RBM BFHR3712 Bone Level Mini Angled Abutment BMAA37151 Bone Level Impression Coping Pick-up Short BICP45S Tissue Level Wide Hybrid Fixture TWFHR5508 Bone Level Implant Hand Piece Drivers BFDML Bone Level Solid Abutment BSA5520 Octa Digital Analog BODLA Regular Sleeve SLVNL Bone Level Healing Abutment BHA6530 Bone Level Angled Abutment BAA55152 Bone Level Fixture Hybrid RBM BFHR4808 Bone Level Angled Abutment BAA65254 Surgical Guide Driver Ratchet Wide Short SGDRWS Bone Level O-Ring Abutment BORA20 Tissue Level Hybrid Fixture TFHR4814 O-ring Lab-Analog ORLA Tissue Level Solid Abutment Large Lab-Analog TSALLA55 Tissue Level Couple Abutment Wide TCAW20 Bone Level Mini Healing Abutment BMHA3750 Surgical Guide Mini Driver Ratchet Narrow Short SGMDRNS Bone Level Fixture Hybrid RBM BFHR4310 Tissue Level Hybrid Fixture TFHR3712 Octa Abutment Plastic Cylinder OAPICy Bone Level Mini Abutment Screw BAS Bone Level Mini Solid Abutment Impression Cap BMSAICap37 Surgical Guide Driver Machine Wide Short SGDMWS Bone Level Mini Healing Abutment BMHA3735 Surgical Guide Driver Machine Narrow Short SGDMNS Hex Driver Hand Piece Long 1.2HDML Bone Level Fixture Hybrid RBM BFHR4814 Torque Controlled Ratchet T-RATCHET Fix Pin FIXPIN20 Bone Level Mini Solid Abutment BMSA3720 Octa Abutment Titanium Cylinder Non-Octa OATICyN Bone Level Couple Abutment H7 BCA65507 Surgical Guide Driver Machine Wide Long SGDMWL Bone Level Angled Abutment BAA55252 Straight Drill SD2208, SD2210, SD2212, SD2214, SD2808, SD2810, SD2812, SD2814 Bone Level Mini Couple Abutment H7 BMCA37407 Octa Abutment Lab-Analog OALA Bone Level Implant Mini Ratchet Drivers BMFDRL Surgical Guide Mini Driver Machine Narrow Long SGMDMNL Bone Level Octa Abutment BOA20 Bone Level Healing Abutment BHA5540 Bone Level Mini Fixture Straight RBM BMFSR3308 Bone Level Mini Couple Abutment H7 BMCA37507 Bone Level Solid Abutment BSA6520 Bone Level Mini Octa Abutment BMOA10 Tissue Level Closing-Screw Small TCLSS Paralel Pin PP2.2 Surgical Guide Spoon Wide/Narrow SGSpWN Surgical Guide Driver Ratchet Narrow Short SGDRNS O-Ring Retainer 500 gr ORRO-y Bone Level O-Ring Abutment BORA05 Narrow sleeve SLVNLY Bar Burnout IB Depth Gauge DP3.7, DP4.3 Surgical Guide Bone Mill Wide SGBMW Impression Coping Octa Abutment Pickup ICOAP Tissue Level Solid Abutment Lab-Analog TSALA55 Bone Level Mini Couple Abutment H7 BMCA37307 Tissue Level SynOcta Abutment TSOA Bone Level Closing Screw BCLS Implance Dental Implant System & Implance Dental Abutment System Surgical Guide Mini Driver Ratchet Narrowly Long SGMDRNLyL Tissue Level Hybrid Fixture TFHR4812 Tissue Level O-Ring Abutment TORA05 Bone Level Mini O-Ring Abutment BMORA40 Bone Level Mini Couple Abutment H7 BMCA37107 Prostetic Kit BTPK Bone Level Mini Healing Abutment BMHA3725 Octa Abutment Healing Cap OAHCAP-L Bone Level Angled Abutment BAA45254 Bone Level Solid Abutment BSA5550 Bone Level Fixture Hybrid RBM BFHR3710 Bone Level Healing Abutment BHA5550 O-Ring Lab-Analog ORLA Tissue Level Octa Abutment TOA Bone Level Healing Abutment BHA4540 Tissue Level Solid Abutment TSA55 Tissue Level O-Ring Abutment TORA40 Tissue Level Impression Coping Pick-Up TICP Bone Level Mini Fixture Straight RBM BMFSR3312 Bone Level Healing Abutment BHA4510 Bone Level Healing Abutment BHA6520 Tissue Level Couple Abutment TCA20 Tissue Level Abutment Screw TAS Bone Level Fixture Hybrid RBM BFHR3714 Tissue Level Hybrid Fixture TFHR4810 Surgical Guide Driver Machine Narrow Long SGDMNL Bone Level Mini Impression Coping Pick-up Long BMICP37L Surgical Guide Neck Drill SGND33, SGND37, SGND43, SGND48 Bone Level Wide Fixture Hybrid RBM BWFHR5512 Bone Level Mini O-Ring Abutment BMORA20 Bone Level Mini Solid Abutment BMSA3730 Tapered Drill TD4314, TD4808, TD4810, TD4812, TD4814, TD5508, TD5510, TD5512 Bone Level Mini Closing Screw BMCLS Bar Positioning Burnout IBP Octa Abutment Ti-Base Cap OTB Bone Level Mini Fixture Straight RBM BMFSR3314 Bone Level Solid Abutment BSA5530 Tissue Level Healing Abutment Wide THAW55 Bone Level Fixture Hybrid RBM BFHR4314 Bone Level Fixture Hybrid RBM BFHR4812 Bone Level Healing Abutment BHA5520 Bone Level Solid Abutment BSA4550 Bone Level Mini Scan Body PMSB Tissue Level Solid Abutment Large TSAL70 Tissue Level Wide Scan Body TWSB Bone Level Mini Octa Abutment BMOA20 Tissue Level Solid Abutment Large TSAL50 Bone Level Solid Abutment BSA4540 Tissue Level Hybrid Fixture TFHR4314 Bone Level Healing Abutment BHA4520 Surgical Guide Spoon Wide/Narrowly SGSpWNLY Pilot Drill PLD, PD Hex Driver for Ratchet Long 1.2HDRL Surgical Guide Mini Driver Machine Narrow Short SGMDMNS Bone Level Implant Mini Ratchet Drivers BMFDRS Bone Level Couple Abutment H7 BCA45307 Tissue Level Fixture Lab-Analog TFLA Bone Level Couple Abutment H7 BCA55407 Tissue Level Healing Abutment Wide THAW35 Tissue Level Hybrid Fixture TFHR4312 Bone Level Mini Octa Abutment BMOA30 Tissue Level Healing Abutment THA35 Surgical Kit Implant BTSK Bone Level Mini Solid Abutment Lab-Analog BMSALA37 Bone Level Fixture Hybrid RBM BFHR4308 Surgical Guide Straight Drill SGSD2808, SGSD2810, SGSD2812, SGSD2814 Fix Screw FIX15, FIX17, FIX20 Tissue Level O-Ring Abutment TORA20 Tissue Level Implant Ratchet Drivers TFDRS Impression Coping Octa Abutment Pickup Non-Octa ICOAPN Bone Level Mini Octa Abutment BMOA50 Bone Level Angled Abutment BAA55254 Octa Abutment Driver Short OADS Bone Level Mini Fixture Lab-Analog BMFLA Bone Level Healing Abutment BHA4550 Bar Matrix Insert Adaptor BMIA Bone Level Impression Coping Pick-up Long BICP45L Tissue Level Solid Abutment Large TSAL40 Bone Level Healing Abutment BHA6510 O-ring Abutment Driver Short ORADS Bone Level Healing Abutment BHA6540 Tissue Level Healing Abutment THA55 Bone Level Couple Abutment H7 BCA65207 Bone Level Fixture Hybrid RBM BFHR4312 Surgical Guide Mini Driver Machine Narrowly Short SGMDMNLyS Hex Driver for Ratchet Extra Short 1.2HDRXS Bone Level Angled Abutment BAA45154 Surgical Guide Driver Ratchet Wide Long SGDRWL ORRO Insert Adaptor OIA Bone Level Solid Abutment BSA6550 Tissue Level Hybrid Fixture TFHR3708 Bone Level Mini Impression Coping Transfer S BMICT37S Bone Level Solid Abutment BSA6540 Tissue Level Hybrid Fixture TFHR3714 Bone Level Couple Abutment H7 BCA55207 Octa Scan Body POSB Impression Coping Octa Abutment Transfer ICOAT Tissue Level Impression Coping Transfer TICT Bone Level Couple Abutment H7 BCA65407 Bar Clip Red IBClip-r Bone Level Healing Abutment BHA5510 Bone Level Impression Coping Pick-up Short BICP65S Tissue Level Couple Abutment TCA30 Bone Level Octa Abutment BOA30 O-Ring Directional Rings (3 pcs with 0, 7, 14 Degrees) ORR-A Bone Level Couple Abutment H7 BCA65107 Tissue Level Solid Abutment TSA70 Tissue Level Implant Hand Piece Drivers TFDML Surgical Guide Bone Mill Narrowly SGBMNLY Tissue Level Closing-Screw Large TCLSL Tissue Level Hybrid Fixture TFHR4310 Bone Level Solid Abutment BSA4510 Bone Level Couple Abutment H7 BCA55307 Bone Level Octa Abutment BOA40 Surgical Guide Mini Driver Machine Narrowly Long SGMDMNLyL Bone Level Angled Abutment BAA45252 Bone Level Fixture Hybrid RBM BFHR3708 Tissue Level Impression Coping Pick-Up Wide TICPW O-ring Abutment Driver Long ORADL Impression Coping Octa Abutment Transfer Non-Octa ICOATN Bone Level Healing Abutment BHA5530 Bar Clip Yellow IBClip-y Bone Level Mini Impression Coping Pick-up Short BMICP37S Bone Level Solid Abutment BSA5510 Surgical Guide Straight Drill SGSD2208, SGSD2210, SGSD2212, SGSD2214 Neck Drill ND3.3, ND3.7, ND4.3, ND4.8, ND5.5 Bone Level Solid Abutment Lab-Analog BSALA45 Bone Level Couple Abutment H7 BCA65307 Surgical Guide Tapered Drill SGTD3708, SGTD3710, SGTD3712, SGTD3714, SGTD4308, SGTD4310, SGTD4312, SGTD4314 Bone Level Couple Abutment H7 BCA45507 Bone Level Couple Abutment H7 BCA55107 Bone Level Solid Abutment BSA6510 Tissue Level Digital Analog TFDLA Wide Sleeve SLVNW Tissue Level Wide Digital Analog TWFDLA Bar Housing Burnout IBH Bone Level Mini Implant Hand Piece Drivers BMFDML Bone Level Couple Abutment H7 BCA55507 O-Ring Retainer 900 gr ORRO-p Tissue Level Hybrid Fixture TFHR4808 Tissue Level Couple Abutment Wide TCAW10 Surgical Guide Driver Ratchet Narrow Long SGDRNL Tissue Level Wide Hybrid Fixture TWFHR5512

Establishment Types

Manufacture Medical Device