Dentapreg® INTRO D-560

Dentapreg® INTRO D-560 is a Class II device made by ADM, a.s., cleared under FDA 510(k) K952353 on 10 Aug 1995 and listed in FDA GUDID since 22 Nov 2016 (UDI-DI 08595652700481), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08595652700481 UDI-DI	Date22 Nov 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK952353	Date10 Aug 1995Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08595652700481
FDA 510(k) database 510(k) number K952353

Across registries

2 registries list this device

FDA 510(k) K952353 decided 10 Aug 1995 Active
FDA GUDID UDI-DI 08595652700481 listed 22 Nov 2016 Listed

Timeline

2 dated events

10 Aug 1995 Cleared FDA 510(k) K952353
22 Nov 2016 Listed FDA GUDID 08595652700481

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Dentapreg® INTRO
Generic name: Dental reinforcing fibre
Model / reference: D-560

Primary DI / UDI-DI: 08595652700481
510(k) Number: K952353
FDA product code: EBF
GMDN term: Dental reinforcing fibre

Device class: Class II
Regulation number: 872.3690
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Lot / batch number
Expiration date

Other properties (12, all answered No)