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Device Explorer · FDA GUDID · GMDN 64312

Dental prosthesis/implant abutment screw analog, single-use

A device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Some types are referred to as a guide pin, and

US‑registered devices676in commercial distribution
Companies21labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Izenimplant Co., Ltd.41561%
Ace Surgical Supply Co., Inc.447%
Preat Corporation386%
Smart Denture Conversions, Llc365%
Sin Sistema De Implante Nacional S/A345%
Noris Medical Ltd264%
Paltop Advanced Dental Solutions Ltd173%
Inosys, Inc.152%

Top labelers

CompanyDevicesShare
Izenimplant Co., Ltd.41561%
Ace Surgical Supply Co., Inc.447%
Preat Corporation386%
Smart Denture Conversions, Llc365%
Sin Sistema De Implante Nacional S/A345%
Noris Medical Ltd264%
Paltop Advanced Dental Solutions Ltd173%
Inosys, Inc.152%
Oco Biomedical Inc122%
Snucone Co.,Ltd.81%
Adin Dental Implant Systems Ltd71%
Aetonmedical Llc51%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

UNP CloseFit™ Close Tray Transfer Screw ShortUNP CloseFit™ Open Tray Transfer Screw ShortNP CloseFit™ Open Tray Transfer Screw ShortNP CloseFit™ Close Tray Transfer Screw ShortRS Open Tray Transfer Screw LongRS Open Tray Transfer Screw ShortTransferPaltopNP CloseFit™ Close Tray Transfer ScrewLITEXSeparable Fastener Assembly 10PK - Drill Kit IncRecharge Kit w/ Tall Spare Parts, TSVPremium Starter Kit, TSVTall Separable Fastener 10PK, ZimVieSeparable Fastener 10PK, ZimVieSeparable Fastener Assembly 10PK - Drill Kit Inc

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NDPAccessories, Implant, Dental, Endosseous570
NDPAccessories, implant, dental, endosseous68
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM27
EJXAnchor, Preformed9
DZEImplant, Endosseous, Root-Form9
NHAAbutment, Implant, Dental, Endosseous8

GMDN & GCC registration

  • GMDN code 64312 · non‑implantable
  • Single‑use 99% · sterile 0% · Rx‑only 94% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many dental prosthesis/implant abutment screw analog, single-use products are registered in the US?

676 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental prosthesis/implant abutment screw analog, single-use", from 21 companies. The largest labeler is Izenimplant Co., Ltd. with 61% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), NDP (Accessories, implant, dental, endosseous), DZE (IMPLANT, ENDOSSEOUS, ROOT-FORM), EJX (Anchor, Preformed)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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