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Dentapreg® BRAID

by ADM, a.s.

Ref D-602

Dentapreg® BRAID (D-602) is a device classified as Class IIa in the EU and Class II in the US made by ADM, a.s., registered in EUDAMED on 29 Aug 2025 (Basic UDI-DI 85956527BRAIDWK), cleared under FDA 510(k) K952353 on 10 Aug 1995 and listed in FDA GUDID since 22 Nov 2016 (UDI-DI 08595652700504), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K952353

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number85956527BRAIDWK Basic UDI-DI 08595652700504UDI-DIDate29 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08595652700504 UDI-DI Date22 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK952353 Date10 Aug 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 85956527BRAIDWK registered 29 Aug 2025 Active
  • FDA 510(k) K952353 decided 10 Aug 1995 Active
  • FDA GUDID UDI-DI 08595652700504 listed 22 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K952353
  2. Listed FDA GUDID 08595652700504
  3. Registered EUDAMED 85956527BRAIDWK

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Dental reinforcing fibre
Model / reference
D-602
Primary DI / UDI-DI
08595652700504
Basic UDI-DI
85956527BRAIDWK
510(k) Number
FDA product code
EBF
EMDN code
Q010299 Prosthetic dentistry devices - other
GMDN term
Dental reinforcing fibre
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Standard device
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa 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
CZ-MF-000032589

Similar devices in this category

Other devices filed under PROSTHETIC DENTISTRY DEVICES - OTHER.

Other devices from ADM, a.s.

See all devices from ADM, a.s. →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)