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Device Explorer · FDA GUDID · GMDN 44575

Dental impression spacer

A device comprised of thin layers of wax or other plastic materials intended to be applied to the surface of edentulous ridges and dental structures before the preliminary application of impression material. After producing the preliminary model, the device is

US‑registered devices52in commercial distribution
Companies8labelers on GUDID
Single‑use50%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Gc America Inc.3058%
Zest Anchors, Llc1019%
Preat Corporation510%
Sterngold Dental Llc36%
Coho Biomedical Technology Co., Ltd.12%
Oco Biomedical Inc12%
Prismatik Dentalcraft, Inc12%
Kerr Corporation12%

Top labelers

CompanyDevicesShare
Gc America Inc.3058%
Zest Anchors, Llc1019%
Preat Corporation510%
Sterngold Dental Llc36%
Coho Biomedical Technology Co., Ltd.12%
Oco Biomedical Inc12%
Prismatik Dentalcraft, Inc12%
Kerr Corporation12%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ZiboneLOCATOR®PreatHader BarHaderMOR® Blockout Shim (25)Stern Root Anchor Laboratory Spacers, 5Blockout Spacers (10)LOCATOR, compatible with Implant DirectLOCATOR, Dentsply Sirona SystemLOCATOR, compatible with Ankylos SystemLOCATOR F-TxLOCATOR R-TxOCO LOK BLOCK OUT SPACERInclusiveGC OCCLUSAL MATRIX SYSTEM

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

FDA product codes

CodeNameDevices
EBHMATERIAL, IMPRESSION TRAY, RESIN28
NDPAccessories, implant, dental, endosseous10
NDPAccessories, Implant, Dental, Endosseous7
EGGAttachment, Precision, All2
DZNINSTRUMENTS, DENTAL HAND2
ELWMATERIAL, IMPRESSION2

GMDN & GCC registration

  • GMDN code 44575 · non‑implantable
  • Single‑use 50% · sterile 0% · Rx‑only 96% · 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

Total Volume (Milliliter) · 12Weight (Pound) · 6Total Volume (Fluid Ounce) · 2Outer Diameter (Millimeter) · 1

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

How many dental impression spacer products are registered in the US?

52 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental impression spacer", from 8 companies. The largest labeler is Gc America Inc. with 58% of records.

Which FDA product codes apply?

EBH (MATERIAL, IMPRESSION TRAY, RESIN), NDP (Accessories, implant, dental, endosseous), NDP (Accessories, Implant, Dental, Endosseous), EGG (Attachment, Precision, All)

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.

How do I get quotes?

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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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