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Silkon Plus

FDA UDI

Class II (US FDA UDI)

by American Orthodontics

Identity

Trade Name
Silkon Plus FDA UDI
Generic Name
Orthodontic bracket, plastic, single-use FDA UDI
Device Name
COSMETIC SILKON UR CUSPID 022 T+5 A+10 R=0 FDA UDI
Model / Reference
002-974M FDA UDI
Description
COSMETIC SILKON UR CUSPID 022 T+5 A+10 R=0 FDA UDI

Identifiers

Catalog Number
002-974M FDA UDI
Primary DI / UDI-DI
00190746003936 FDA UDI
510(k) Number
K891372 FDA UDI
FDA Product Code
DYW FDA UDI
GMDN Term
Orthodontic bracket, plastic, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5470 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Silkon Plus by American Orthodontics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K891372 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Orthodontics

Sources (1)

  • FDA UDI 20f1b55d-8efb-4f94-a284-7f4aeb88f23d 37 fields · synced Jun 9, 2026