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O-Tray Trans. Fix. Screw TXOTFS2.0

by Paragon Implant Mfg., LLC

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 Number00810157315175 UDI-DI Date21 Sep 2026ListedStatusListed 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  • Withdrawn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
O-Tray Trans. Fix. Screw
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Model / Ref / Catalog
TXOTFS2.0
Primary DI / UDI-DI
00810157315175
510(k) Number
FDA Product Code
NHA
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class II
Regulation Number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional
Size
Outer Diameter — 3.0 Millimeter
Length — 2.5 Millimeter

Related devices

Cleared under the same submission (K261392)

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Properties

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

Other properties (8)

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