Silkon Plus 002-911MB

by American Orthodontics

Silkon Plus 002-911MB is a Class II device made by American Orthodontics, cleared under FDA 510(k) K891372 on 31 Mar 1989 and listed in FDA GUDID since 9 Nov 2016 (UDI-DI 00190746003271), 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	Number00190746003271 UDI-DI	Date9 Nov 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK891372	Date31 Mar 1989Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00190746003271
FDA 510(k) database 510(k) number K891372

Across registries

2 registries list this device

FDA 510(k) K891372 decided 31 Mar 1989 Active
FDA GUDID UDI-DI 00190746003271 listed 9 Nov 2016 Listed

Timeline

2 dated events

31 Mar 1989 Cleared FDA 510(k) K891372
9 Nov 2016 Listed FDA GUDID 00190746003271

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Silkon Plus
Generic name: Orthodontic bracket, plastic, single-use
Model / Ref / Catalog: 002-911MB

Primary DI / UDI-DI: 00190746003271
510(k) Number: K891372
FDA product code: DYW
GMDN term: Orthodontic bracket, plastic, single-use

Device class: Class II
Regulation number: 872.5470
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Prescription use
Lot / batch number
Manufacturing date

Other properties (11, all answered No)