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Device Explorer · FDA GUDID · GMDN 46423

Gingival retraction solution

A liquid substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva typically through the action of an astringent agent (e.g., al

US‑registered devices81in commercial distribution
Companies11labelers on GUDID
Single‑use40%of device records
Sterile0%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Pascal Company, Inc.1721%
Vista Dental1721%
Premier Dental Products Company1519%
Henry Schein, Inc.911%
The Atlanta Dental Supply Company67%
Ultradent Products, Inc.56%
Kulzer Gmbh56%
Voco Gmbh34%

Top labelers

CompanyDevicesShare
Pascal Company, Inc.1721%
Vista Dental1721%
Premier Dental Products Company1519%
Henry Schein, Inc.911%
The Atlanta Dental Supply Company67%
Ultradent Products, Inc.56%
Kulzer Gmbh56%
Voco Gmbh34%
Den-Mat Holdings, Llc22%
Dentsply International Inc.11%
Benco Dental Supply Co.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VOCO Retraction PasteViscoStat ClearAdvance Dental ProductsHemoban® Gel 25% Aluminum Chloride Hemostatic SoFASTRACTTissue Goo™ Hemostatic Gel Big Shot Syringe KitTissue Goo™ Hemostatic Gel 4-PackTraxodentHemodentTraxodent - ItenaRetrax AC SolutionRetrax Gel FS ProPack SAMPLEEU Retrax Gel AS ProPack SampleEU Retrax Gel FS ProPack SampleRetrax Gel FS ProPackEU Retrax Gel AS Clear ProPack

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

FDA product codes

CodeNameDevices
MVLCord, Retraction58
MVLCORD, RETRACTION20
DSPSystem, balloon, intra-aortic and control3

GMDN & GCC registration

  • GMDN code 46423 · non‑implantable
  • Single‑use 40% · sterile 0% · Rx‑only 94% · 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) · 13Total Volume (Milliliter) · 2

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

How many gingival retraction solution products are registered in the US?

81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gingival retraction solution", from 11 companies. The largest labeler is Pascal Company, Inc. with 21% of records.

Which FDA product codes apply?

MVL (Cord, Retraction), MVL (CORD, RETRACTION), DSP (System, balloon, intra-aortic and control)

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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