BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    RHEIN 83 SRL

    Reg #: 9680939 · FEI: 3002807996 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    86
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    RHEIN 83 SRL
    Registration Number
    9680939
    FEI Number
    3002807996
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA EMILIO ZAGO 10abc
    City
    BOLOGNA Emilia-Romagna
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K171409

    Owner / Operator

    Firm Name
    RHEIN83 SRL
    Operator Number
    9012485
    Address
    VIA EMILIO ZAGO 10
    City
    BOLOGNA
    State
    IT-BO
    Postal Code
    40128
    Country
    IT
    Correspondent
    GIANNI STORNI

    US Agent

    Business Name
    American Recovery
    Contact Name
    Joseph J. Tambasco
    Address
    466 Main Street, Lower Level
    City
    New Rochelle
    State
    NY
    ZIP
    10801
    Country
    US
    Email
    [email protected]
    Phone
    914 6323800 ext. 0

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Anchor, Preformed EJX
    Accessories, Implant, Dental, Endosseous NDP
    Attachment, Precision, All EGG
    Gauge, Depth, Instrument, Dental EIL
    Post, Root Canal ELR
    Drill, Dental, Intraoral DZA
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    486ICS-US OT STRATEGY EXTR./INSERTION TOOL W. UDI 485IC-US-SIS CAPS EXTR./INSERTION TOOL W. UDI 185SIS-US SEEGER METAL INSERTION TOOL W. UDI 491EC-US CAP EXTRACTOR TOOL W. UDI 774CHE-DIO OT EQUATOR SQUARE SCREW DRIVER + HOLDER 144AE-DIO LABORATORY ANALOGS 2 units 760CRD-US-DIO RATCHET TORQUE CONTROL DEVICE W. UDI 760CRD-US-SIS MANUAL TORQUE WRENCH W. UDI 485IC-US-IQ EQUATOR/OT CAPS INSERTER/EXTRACTOR TOOL 124IMR-US REVERSE 3 INSERTION TOOL W. UDI 488EIP-US-IQ CAPS EXTRACTOR/INSERTION TOOL W. UDI 485IC INSERTION/EXTRACTION TOOL FOR CAPS 085IAC-US CAPS INSERTION TOOL W. UDI 485IC-US CAPS EXTR./INSERTION TOOL W. UDI 760CRD-US MANUAL TORQUE WRENCH W. UDI 044CAIN-DIO IMPRESSION COPING 2 units 488EIP-US CAPS EXTR./INSERTION TOOL W. UDI 472ICV-US OT VERTICAL EXTR./INSERTION TOOL W. UDI 429IOBM-US OT BAR EXTR./INSERTION TOOL W. UDI 485IC-US-DIO MULTIUSE CAP INSERTER/EXTRACTOR TOOL Z-ILZ-ICT IMPRESSION COPING TRANSFER ILZ Z-ILZ-LA LAB ANALOGUE ILZ Z-I-KIT-EQ Insertion-Extraction tool Set EQ 0003-US INSTRUMENT SET (CAI) Z-EQ-ICT IMPRESSION COPING TRANSFER EQ Z-ILZ-HC HEALING CAP TEMP ILZ Z-EQ-LA LAB ANALOGUE EQ OT CAP; OT STRATEGY; OT REVERSE 3; OT EQUATOR PROFILE; SINGLE SPHERE AND ACCESSORIES 141CCN-IQ DENTURE REPLAC.HOUSING ASSEMBLY (4 Pack) 140CEADR8 OT EQUATOR CAP ORANGE INT. ø 2,2MM 4u. 140CEG-IQ EQUATOR RET.CAPS SOFT,YELLOW (4 Pack) 140CER OT EQUATOR PINK CAPS 4u. 140CEN-IQ EQUATOR CAPS LAB.PROCESSING, BLACK (4 p) 140CEG-DIO RETENTIVE CAPS-YELLOW "EXTRA SOFT"-600g 140CEG OT EQUATOR YELLOW CAPS 4u. 192ECE-DIO CAPS ASSORTMENT SET 140CET OT EQUATOR CLEAR CAPS 4u. 141CTE OT EQUATOR TITANIUM HOUSINGS 2u. 140CEN-DIO PROCESSING CAPS-BLACK (for lab.use only) 140CER-IQ EQUATOR RET.CAPS SOFT,PINK (4-Pack) 160EQB THREADED OT EQUATOR SET FOR BONDING 141CAE OT EQUATOR S/STEEL HOUSINGS 2u. 140CEN OT EQUATOR BLACK CAPS (lab.only) 4u. 335SBC-DIO SMART BOX SET 140CEV OT EQUATOR VIOLET CAPS 4u. 092ECQ CASTABLE OT EQUATOR W. CAPS & HOUSING 140CEV-IQ Equator ret.Caps Strong,Violet (4-pack) 140CEDR8 OT EQUATOR CAP AQUA C. INT. ø 2,2MM 4u. 192ECE OT EQUATOR CAPS WITH METAL HOUSING 151SS CASTABLE OT EQUATOR 2u. 158ESA OT EQUATOR SELF-EXTR. ELASTIC SEEGER SET Z-EQ-140CER OT EQUATOR PINK RETENTIVE CAPS 4U. Z-EQ-140CEG OT EQUATOR YELLOW RETENTIVE CAPS 4U. Z-EQ-140CEV OT EQUATOR VIOLET RETENTIVE CAPS 4U. Z-EQ-140CET OT EQUATOR CLEAR RETENTIVE CAPS 4U. Z-EQ-140CEN OT EQUATOR BLACK RETENTIVE CAPS 4U. Z-ILZ-RC5 RETENTIVE CAP 5 pieces Kit ILZ Z-EQ-100PD PROTECTIVE DISK pcs.10 Z-EQ-RC6 RETENTIVE CAP 6 pieces KIT EQ CUFF HEIGHT MEASURER Z-EQ-SBOX Retentive EQ Cap Set PIVOT FLEX PIVOT BLOCK; OT REVERSE 3 Z-EQ-131TN433 Equator Tri-Nex ø4.3 x 3mm Kit Z-EQ-131TN357 Equator Tri-Nex ø3.5 x 7mm Kit Z-EQ-131TN356 Equator Tri-Nex ø3.5 x 6mm Kit Z-EQ-131TN437 Equator Tri-Nex ø4.3 x 7mm Kit Z-EQ-131TN353 Equator Tri-Nex ø3.5 x 3mm Kit Z-EQ-131TN53 Equator Tri-Nex ø5 x 3mm Kit Z-EQ-131TN55 Equator Tri-Nex ø5 x 5mm Kit Z-EQ-131TN436 Equator Tri-Nex ø4.3 x 6mm Kit Z-EQ-131TN432 Equator Tri-Nex ø4.3 x 2mm Kit Z-EQ-131TN351 Equator Tri-Nex ø3.5 x 1mm Kit Z-EQ-131TN51 Equator Tri-Nex ø5 x 1mm Kit Z-EQ-131TN352 Equator Tri-Nex ø3.5 x 2mm Kit Z-EQ-131TN52 Equator Tri-Nex ø5 x 2mm Kit Z-EQ-131TN431 Equator Tri-Nex ø4.3 x 1mm Kit 030AS4NC3-DIO DIO Implant UF-UFII Regular Int. Type Z-EQ-131TN355 Equator Tri-Nex ø3.5 x 5mm Kit Z-EQ-131TN56 Equator Tri-Nex ø5 x 6mm Kit Z-EQ-131TN57 Equator Tri-Nex ø5 x 7mm Kit Z-EQ-131TN354 Equator Tri-Nex ø3.5 x 4mm Kit Z-EQ-131TN54 Equator Tri-Nex ø5 x 4mm Kit Z-EQ-131TN435 Equator Tri-Nex ø4.3 x 5mm Kit Z-EQ-131TN434 Equator Tri-Nex ø4.3 x 4mm Kit BROKEN SCREW EXTRACTOR KIT SPHERO FLEX AND BLOCK; OT EQUATOR PROFILE;

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)