Skip to content

Variable Setting Torque Wrench TW-35

by Paragon Implant Mfg., LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00810157314062 UDI-DI Date7 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Variable Setting Torque Wrench
Generic Name
Dental torque wrench
Model / Ref / Catalog
TW-35
Primary DI / UDI-DI
00810157314062
FDA Product Code
NDP
GMDN Term
Dental torque wrench
Device Class
Class I
Regulation Number
872.3980
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 6.0 Millimeter
Length — 100 Millimeter

Other devices from Paragon Implant Mfg., LLC

See all devices from Paragon Implant Mfg., LLC →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No