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Newgear 23-300-03

by Dentsply Sirona Orthodontics Inc.

Listed FDA GUDID listing, not in commercial distribution

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 NumberD80723300031 UDI-DI Date26 Jun 2017ListedStatusListed GUDID: not 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  • Withdrawn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
Newgear
Generic Name
Orthodontic extraoral headgear
Model / Ref / Catalog
23-300-03
Primary DI / UDI-DI
D80723300031
510(k) Number
FDA Product Code
DZB
GMDN Term
Orthodontic extraoral headgear
Device Class
Class II
Regulation Number
872.5500
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K940410)

Show all (12)

Other devices from Dentsply Sirona Orthodontics Inc.

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (10)

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