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APC™ Flash-Free Clarity™ SL 4007-512

by 3M Unitek Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00652221163677 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
APC™ Flash-Free Clarity™ SL
Generic Name
Orthodontic bracket, ceramic
Model / Ref / Catalog
4007-512
Primary DI / UDI-DI
00652221163677
510(k) Number
FDA Product Code
NJM
GMDN Term
Orthodontic bracket, ceramic
Device Class
Class II
Regulation Number
872.5470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic bracket, ceramic

Cleared under the same submission (K062305)

Show all (12)

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No