Consulting Wallah › Device Explorer › Dental › Fatty acid dental cement
Device Explorer · FDA GUDID · GMDN 46939

Fatty acid dental cement

A non-sterile, non-aqueous substance containing fatty acids typically with a mixture of oxides or hydroxides of zinc, magnesium, and/or calcium, that cures upon the acid/base reaction of its components and is intended to be used in a professional setting for t

US‑registered devices171in commercial distribution
Companies13labelers on GUDID
Single‑use6%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Lancer Orthodontics, Inc.7644%
Cosmedent, Inc.3219%
3M Deutschland Gmbh2112%
Kerr Corporation116%
Voco Gmbh106%
Dent Zar, Inc.53%
Gc America Inc.53%
Clinician'S Choice Dental Products, Inc.32%

Top labelers

CompanyDevicesShare
Lancer Orthodontics, Inc.7644%
Cosmedent, Inc.3219%
3M Deutschland Gmbh2112%
Kerr Corporation116%
Voco Gmbh106%
Dent Zar, Inc.53%
Gc America Inc.53%
Clinician'S Choice Dental Products, Inc.32%
Den-Mat Holdings, Llc32%
Darby Dental Supply, Llc21%
Burkhart Dental Supply Co., The11%
The Atlanta Dental Supply Company11%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Cling2® Resin Optimized Temporary Cement 25mLCLING2™ 10ml Dual Syringe KitCLING2™ 5ml Dual Syringe Kit3M™ Cavit™3M™ Protemp™Cavit™ GCavit™ WCavit™RelyX™ Temp NERelyX™ Temp EProvicol QMProvicol QM AestheticProvicol QM PlusProvicolProvicol COlympian-M Temporary Cement, Syringe System

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

FDA product codes

CodeNameDevices
DYHAdhesive, Bracket And Tooth Conditioner, Resin76
EMACement, Dental47
EMACEMENT, DENTAL30
EBGCROWN AND BRIDGE, TEMPORARY, RESIN17
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL8
EMBZINC OXIDE EUGENOL4

GMDN & GCC registration

  • GMDN code 46939 · non‑implantable
  • Single‑use 6% · 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

Weight (Gram) · 14Total Volume (Milliliter) · 6

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

No closely related category with 50+ devices.

How many fatty acid dental cement products are registered in the US?

171 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fatty acid dental cement", from 13 companies. The largest labeler is Lancer Orthodontics, Inc. with 44% of records.

Which FDA product codes apply?

DYH (Adhesive, Bracket And Tooth Conditioner, Resin), EMA (Cement, Dental), EMA (CEMENT, DENTAL), 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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