Home GUDID 08059224087139 SPHERO FLEX
Primary DI 08059224087139
Brand SPHERO FLEX
Company RHEIN 83 SRL
Model SPHERO FLEX ANKYLOS C/X h.1
Catalog number 109ANKCX1R
Device description DISPOSABLE medical device to be screwed into a dental implant. The connection and the thread are compatible with the specific implant. Available in different cuff heights. Retentive caps, metal housing for the caps, directional rings and protective disc.
Published 2021-07-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name EGG Attachment, Precision, All
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EGG Attachment, Precision, All Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D821109ANKCX1R0 Previous HIBCC 0 08059224087139 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08059224087139 08059224087139 8059224087139
GMDN Terms# Term, Definition table Term Definition Dental implant suprastructure, permanent, preformed A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 439240722 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08059224094229 OT EQUATOR TITANIUM ABUTMENT OT EQUATOR XIVE TG h.3 230XIVTG3 2026-02-10 08059224115801 PLUS PLUS CAP EXTRACTOR-INSERTER 488EIP 2026-02-10 08059224127798 OT EQUATOR OT EQUATOR CLEAR CAP #100 CN051-100 2026-02-10 08059224129044 PLUS PINK CAP PLUS #50 CN087-50 2026-02-10 08059224129099 PLUS YELLOW CAP PLUS #50 CN088-50 2026-02-10 08059224129143 PLUS VIOLET CAP PLUS #50 CN089-50 2026-02-10 08059224133041 OT EQUATOR PINK PROTECTIVE DISK #100 DPR-100 2026-02-10 08059224133058 OT EQUATOR PINK PROTECTIVE DISK #50 DPR-50 2026-02-10 08059224134260 OT EQUATOR SMART BOX OT EQUATOR #50 SBE-50 2026-02-10 08059224140148 OT EQUATOR LABORATORY ANALOGS 50 u. AAE-50 2026-02-10 08059224167497 PLUS Transfer Heli-Loc open 044CAIP-HE 2026-02-10 08059224167503 PLUS Laboratory set Standard (with pin) 192CPC-HE 2026-02-10 08059224167510 PLUS Laboratory set Extended (without pin) 192CPS-HE 2026-02-10 08059224167527 OT EQUATOR Extraction/insertion tool for caps 488EIP-HE 2026-02-10 08059224167534 PLUS Cap without pin yellow (0,6kg / 1,32lbs) 140CPG-HE 2026-02-10 08059224167541 PLUS Cap without pin black (lab use) 140CPN-HE 2026-02-10 08059224167558 PLUS Cap without pin pink (0,8kg / 1,76lbs) 140CPP-HE 2026-02-10 08059224167565 PLUS Cap with pin yellow (0,7kg / 1,54lbs) 140CPPG-HE 2026-02-10 08059224167572 PLUS Cap with pin black (lab use) 140CPPN-HE 2026-02-10 08059224167589 PLUS Cap with pin pink (0,9kg / 1,98lbs) 140CPPP-HE 2026-02-10
Other Devices Sharing Product Codes#