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PrimaDry

by Ultradent Products, Inc.

Ref 717, 716

PrimaDry (717) is a dental pit/fissure sealant (EU MDR Class I; FDA Class II; FDA product code EBC, Sealant, Pit and Fissure, and Conditioner) made by Ultradent Products, Inc., registered in EUDAMED on 1 Apr 2026 (Basic UDI-DI 0883205-TF018PrimaDryFV) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205103826), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-TF018PrimaDryFV Basic UDI-DI Date1 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205103826 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF018PrimaDryFV registered 1 Apr 2026 Active
  • FDA GUDID UDI-DI 00883205103826 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00883205103826
  2. Registered EUDAMED 0883205-TF018PrimaDryFV

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Dental pit/fissure sealant
Model / Ref / Catalog
717, 716
Primary DI / UDI-DI
00883205103826, 00883205103833
Basic UDI-DI
0883205-TF018PrimaDryFV
FDA product code
EBC
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Dental pit/fissure sealant
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3765
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000013697
Authorised representative
Ultradent Products GmbH DE-AR-000006666

Similar devices in this category

Other devices filed under CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)