FDA Registration Active 🇮🇹 Italy

Kerr Italia, S.r.l.

Reg #: 8020994 · FEI: 1000231788 · Expires 2026
Products
24
Proprietary Names
325
Establishment Types
4
Classifications
24

Registration Details

Registration Name
Kerr Italia, S.r.l.
Registration Number
8020994
FEI Number
1000231788
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Via Passanti, 174
City
SCAFATI Salerno
Country
IT

Regulatory Submissions

510(k) Number
K162257

Owner / Operator

Firm Name
SYBRON DENTAL SPECIALTIES, INC.
Operator Number
9029565
Address
1889 W Mission Blvd, --
City
Pomona
State
CA
Postal Code
91766
Country
US
Correspondent
Jennifer Evans

US Agent

Business Name
Sybron Dental Specialties
Contact Name
Jennifer Evans
Address
1717 W Collins Ave
City
Orange
State
CA
ZIP
92867
Country
US
Phone
714 5167795

Products

Device Name Product Code
Liner, Cavity, Calcium Hydroxide EJK
Material, Tooth Shade, Resin EBF
Agent, Tooth Bonding, Resin KLE
File, Pulp Canal, Endodontic EKS
Bur, Dental EJL
Cement, Dental EMA
Material, Impression ELW
Agent, Polishing, Abrasive, Oral Cavity EJR
Point, Abrasive EHL
Sealant, Pit And Fissure, And Conditioner EBC
Zinc Oxide Eugenol EMB
Cord, Retraction MVL
Point, Paper, Endodontic EKN
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief MZW
Unit, Operative Dental EIA
Instrument, Diamond, Dental DZP
Plugger, Root Canal, Endodontic EKR
Gutta-Percha EKM
Retainer, Matrix JEP
Reamer, Pulp Canal, Endodontic EKP
Syringe, Restorative And Impression Material EID
Instruments, Dental Hand DZN
Resin, Root Canal Filling KIF
Disk, Abrasive EHJ

Proprietary Names

Life Harmonize Composite SimpliShade Composite Silane Silane Primer TF Adaptive Files Traverse Files TF (Twisted Files) ZenFlex Files Triple Flex Files K-Files LA Axxess Hedstrom Files Barbed Broach Pathfinder K-Flex Files Pathfinder CS K3XF Files Quantec Files ZenFlex One Sterile and Non-Sterile Files Traverse Orifice and Glide Path File Quantec Axxess Files Traverse Orifice Opener LightSpeed LSX K3 Files Root Canal Reamers LightSpeed CRX Traverse Glide Path File FibreKor Fiber Post Drill FibreKleer 4X Fiber Post Drill Kerr Carbides Post Drills Bur Block Hawe Jet Carbides Jet Carbides BluWhite Carbides Axis Carbide Burs LVI Aesthetic Inlay/Onlay Logic Set GrayGates IPR Logic Set R.A.P.T.O.R. Resin Sculpting Logic Set MW Series Finishing Logic Set Crown Removal Logic Set Comprehensive Universal Cutter Logic Set Posterior Composite Logic Set TDF Carbide Logic Set Vylon Resources Logic Set Carbide Burs Melker Root Shaping Logic Set NTI Soft Tissue Trimmer Tri-fissure All Ceramic Logic Set E$D Sample Logic Set All-Purpose Esthetic Logic Set TDF Series Personalized Logic Set Endodontic Access Logic Set Lowe Crown & Bridge Logic Set TDF Series Composite Logic Set Razor T&F Carbides Barbed Broaches SimpliShade BulkFill Flow SimpliShade BulkFill Breeze Self-Adhesive Resin Cement Breeze Point 4 Harmonize Super clear Revolution Formula 2 Dispensing Tips AlgiNot OptiBond Solo Plus Biosplint Adhesive Herculite XRV Cleanic Hawe Paste for Implants Luster Paste Prophy Paste Cleanpolish Superpolish Shammy Bright Polishing Paste Clinpro Perfect Pearl and Petite Pearl Prophy Contra Angles and Brushes PORCELAIN / CERAMICS NG Polishers & Prepolishers Pro-Brush GlossPlus Polisher Cup MINIDENTOFLEX Right Angle Mandrel COMPOSITE Glanzpolierer IDF Rec.Gloss Polishers Flame Pin Spannhalter Occlubrush Assorted Kit PINIDENTOFLEX GOLD/PRECIOUS ME PINIDENTOFLEX Pin-Holder MAXI SUPER ACRYLIC POLISHERs IDF Rec.Gloss Polishers Disc Occlubrush Cups & Points HiLuster Plus Polisher cup COMPOSITE Polishers & Prepolishers Opti1Step Polishers DIAMOND COMPOSITE Polishers COMPOSITE Vorpolierer IDF Rec.Gloss Polishers Mini HiLusterPlus Assortment OptiShine OptiClean IDF Rec.Gloss Polishers Cup MINIDENTOFLEX -COMPOSITE Polishers & Prepolishers Hawe Bristle Brushes IDF Rec.HiLuster Dia Polishers Hawe Polishing Assorted Kit GOLD/ AMALGAM / PRECIOUS METAL Polishers NTI Acrylic Polisher Ultimate FG IntraOral Logic Set CeraGlaze Porcelain Polishing Logic Set Prophy Brushes Zir-Cut Polisher Logic Set Cera-Glaze Ultimate Porcelain Logic Set NTI Green Abrasive Pro-Cup Latch Type Soft DiaGloss Polishing Logic Set Zir-Cut Zirconia Polisher Ortho Adhesive Removal Logic Set Acrylic Adjustment Logic Set NTI DiaGloss Polisher NTI PDQ Polisher AXIS Laminate Veneer Set NTI Brown Abrasive NTI Silicone Polisher CeraGlaze Intra-Oral Polishing Logic Set Valplast Logic Set UltraGloss Composite Polishing Logic Set Porcelain Adjusting & Polishing Logic Set Polisher Century Pack CeraGlaze Porcelain Lab Logic Set Razor Sculpt and Polishing Logic Set Shammy Bright Discs NTI White Abrasive NTI Pink Abrasive PDQ Composite Polishing Brush Logic Set NTI Goldstar E4D Chairside Dental Designer Logic Set NTI CeraGlaze NTI PDQ2 Polisher ProGloss Ultimate Composite Polishing Logic Set Goldstar Gold Polishing Logic Set E4D Preparation Logic Set Pro-Cup Junior, Latch Type, Standard PDQ2 Composite Polishing Logic Set E4D Sdjust & Polish Logic Set Bite Adjustment Logic Set Interdental Wedges Clinical CAD/CAM Preparation Logic Set Pro-Cup Junior, Screw-Type, Standard Pro-Cup, Screw-Type, Soft NX3 Nexus Third Generation Nexus NX3 NX3 Flow-It ALC SonicFill 2 SonicFill 3 37% Phosphoric Acid Etching Gel OptiBond Gel Etchant Etching Gel Embonte Temp-Bond Original Take 1 Advanced Rigid Tray Permlastic Permlastic Adhesive Integra Take 1 Advanced Putty OptiBond FL Styptin Hemodettes GingiGEL Hemogin-L Take 1 Advanced TF Adaptive Paper Points K3/K3XF Paper Points ZenFlex ONE Paper Points TF Paper Points Autofit Paper Points PAPER POINTS Maxcem Elite Seal-Tight Chamfer Preparation Logic Set Veneer Preparation Logic Set Axial Reduction - MADC Raintree Essix Logic Set Zir-CUT Substructure Logic Set CEREC Starter Logic Set Belvedere C.C.V. Logic Set CEREC Prep N' Glaze Logic Set TDF Diamond Logic Set LVI Anterior Direct Ressin Preparation Logic Set Hornbrool Prep Logic Set Anterior Composite Logic Set Laminate Veneer Logic Set Axial Reduction Logic Set Nano Diamonds CEREC Prep & Finish Logic Set ZIR-CUT Diamond Bambino Diamonds KS Series Guide Pin Diamond Intensiv ProxoShape Diamond File Zir-Cut DDS Adjusting Logic Set Nano Prep Diamond Logic Set Turbo Chamfer Preparation Logic Set BruxZir Logic Set Reverse Preparation Logic Set Hornbrook Finish Logic Set Logic Set Axis Diamond Burs CEREC Intra-Oral Art & Passion Logic Set R.A.P.T.O.R. Diamond Modified Shoulder Logic Set Turbo Diamonds LAVA Preparation Logic Set Composite Logic Set LVI Esthetic Preparation Logic Set cerecdoctors.com Logic Set Radz & Soileau RSVP Logic Set BluWhite SimpliCut Pre-Sterile Diamond Burs SimpliShade Bleach White Herculite Ultra Herculite XRV Ultra OptiShade Bleach White OptiBond Universal OptiBond All-In-One elements IC PacMac Heat Plugger Buchanan Hand Plugger Condensor K3XF Gutta Percha Elements Gutta Percha Cartridge TF Adaptive Gutta Percha SoftCore TF Adaptive Obturator TF Adaptive Verifiers Gutta Percha Cartridge Zenflex Pre-Tip Gutta Percha Gutta Percha ZenFlex ONE Gutta Percha Autofit Backfill Gutta Percha SimpliCore Obturator Universal SimpliFill Apical Plugs SimpliCore Obturator for Zenflex One Autofit Gutta Percha K3 Gutta Percha Tip Snip- GP Gauge Wheel with Stand TF Gutta Percha Pre-contoured Metal Bands Cure-Thru Matrices Polishers Wedge Bags SuperCap Matrices, Steel, Cervical Premise Flowable Herculite XRV Ultra Flow Build-It FR Reamers Pulp Canal OptiBond Universal 360 TempBond Clear with Triclosan TempSpan Transparent Temporary Cement TempSpan Transparent Mixing Tips Automix Tips Bayonet Rings Intra-oral Tips Free-Flo Syringe, Tips Root Canal Tips Dynamic Mixing Tips Wastesaver Tips Static Mix Tips Temp-Bond NE Hawe Interdental Wedges Double Plugger Unidose Gun Adapt Luciwedge Dispensing Gun Transparent Cervical Foils & Matrices Luciwedge Blue Transparent Molar & Premolar Bands Composite Filling Spatula Composite Instruments SuperMat Single-Dose Dispensing Gun Blue Cervical Matrices Cure-Thru Cervical Foils TCF-Holder Hawe Tofflemire Matrices Hawe Steel Band Hawe Contoured Tofflemire Band Perforation Repair Cervical Foil & Posterior Blue View Grip Strips Extruder Hand Plugger SuperCap Matrices & Spools Blue Cervical Foils Explorer Curette MetaFix Prophy Clip Stop Strips Pulp Canal Sealer Pulp Canal Sealer EWT Sealapex Sealapex Xpress Tubli-Seal Xpress Tubli-Seal EWT Xpress Tubli-Seal EWT Tubli-Seal Composite Surface Treatment OptiDisc Zone ZoneFree Take 1 Advanced Bite Maxcem Elite Chroma Extrude SimpliShade Self-Adhesive Flow Vertise Flow Premise OptiBond eXTRa Universal

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device