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Device Explorer · FDA GUDID · GMDN 64323

Dental implant abutment impression cap

A small device intended to be placed intraorally on the abutment head of a dental implant during a dental impression to facilitate removal of the impression material once it has hardened, and to reproduce the intraoral position and orientation of the abutment/

US‑registered devices135in commercial distribution
Companies20labelers on GUDID
Single‑use84%of device records
Sterile8%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Oco Biomedical Inc2216%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung2116%
Sterngold Dental Llc1310%
Ossvis Co., Ltd.107%
Snucone Co.,Ltd.97%
Sin Sistema De Implante Nacional S/A97%
Southern Implants (Pty) Ltd75%
Titan Implant Inc75%

Top labelers

CompanyDevicesShare
Oco Biomedical Inc2216%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung2116%
Sterngold Dental Llc1310%
Ossvis Co., Ltd.107%
Snucone Co.,Ltd.97%
Sin Sistema De Implante Nacional S/A97%
Southern Implants (Pty) Ltd75%
Titan Implant Inc75%
Aetonmedical Llc75%
Plasdent Corporation54%
Osseofuse International, Inc.54%
Dentis Co. ,Ltd54%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAZiboneMedicon Epiplating Systemn/aOKTAGON®Open Tray Impression Coping Multi-Unit 5PK, OmniOpen Tray Impression Coping Multi-Unit 5PKBU-UPTITAN IMPLANTS, INC.MOR Comfort Cap 4 packMOR Comfort Cap 10 packHader Bar® Impression CopingMOR Impression CopingStern Snap® Impression CopingPUR® Impression Coping RPPUR® Impression Coping NP

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, Endosseous94
NDPAccessories, implant, dental, endosseous21
NHAAbutment, Implant, Dental, Endosseous16
DZEImplant, Endosseous, Root-Form7
NRDUnit, Operative Dental, Accessories5
EGGAttachment, Precision, All1

GMDN & GCC registration

  • GMDN code 64323 · non‑implantable
  • Single‑use 84% · sterile 8% · Rx‑only 92% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 1Length (Millimeter) · 1

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

How many dental implant abutment impression cap products are registered in the US?

135 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant abutment impression cap", from 20 companies. The largest labeler is Oco Biomedical Inc with 16% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), NDP (Accessories, implant, dental, endosseous), NHA (Abutment, Implant, Dental, Endosseous), DZE (Implant, Endosseous, Root-Form)

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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