Consulting Wallah › Device Explorer › Dental › Preformed dental crown, temporary
Device Explorer · FDA GUDID · GMDN 34976

Preformed dental crown, temporary

A prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary devi

US‑registered devices3,202in commercial distribution
Companies15labelers on GUDID
Single‑use97%of device records
Sterile0%labelled sterile
Prescription40%Rx‑only share
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Share of device records

Nusmile, Ltd.1,32341%
3M Company49515%
Park - Istre, Llc3049%
Kids-E-Dental Llp2217%
Directa Ab1765%
Sprig Oral Health Technologies, Inc.1575%
Hu-Friedy Mfg. Co., Llc1354%
Safco Dental Supply Co.983%

Top labelers

CompanyDevicesShare
Nusmile, Ltd.1,32341%
3M Company49515%
Park - Istre, Llc3049%
Kids-E-Dental Llp2217%
Directa Ab1765%
Sprig Oral Health Technologies, Inc.1575%
Hu-Friedy Mfg. Co., Llc1354%
Safco Dental Supply Co.983%
Henry Schein, Inc.863%
Darby Dental Supply, Llc612%
Specialty Appliances, Llc582%
Produits Dentaires S.A.421%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Restoration, Porcelain Fused to Metal-PFM, CrownRestoration, Resin: Crown, Bridge, Temporary InlDarby Dental Supply, LLCExperTempNuSmile Signature Cuspid Replacement CrownPedo OnBrace Crown LR5 (5/pk)Pedo OnBrace KitOnBrace Kit w/ Archwire TubesOnBrace KitCrown KitROC KitROC Crown 8LLROC Crown 7LLROC Crown 6LLROC Crown 5LLROC Crown 4LL

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

FDA product codes

CodeNameDevices
ELZCrown, Preformed2,374
ELZCROWN, PREFORMED943
EBGCROWN AND BRIDGE, TEMPORARY, RESIN12
EBGCrown And Bridge, Temporary, Resin12

GMDN & GCC registration

  • GMDN code 34976 · non‑implantable
  • Single‑use 97% · sterile 0% · Rx‑only 40% · 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

No structured size data on the register.

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

How many preformed dental crown, temporary products are registered in the US?

3,202 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Preformed dental crown, temporary", from 15 companies. The largest labeler is Nusmile, Ltd. with 41% of records.

Which FDA product codes apply?

ELZ (Crown, Preformed), ELZ (CROWN, PREFORMED), EBG (CROWN AND BRIDGE, TEMPORARY, RESIN), EBG (Crown And Bridge, Temporary, Resin)

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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