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Integrity INT-E

by Osseo Scientific, LLC

Integrity INT-E is a Class I device made by Osseo Scientific, LLC, cleared under FDA 510(k) K070155 on 25 Jan 2007 and listed in FDA GUDID since 18 Jul 2022 (UDI-DI 00850012724209), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K070155

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850012724209 UDI-DI Date18 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK070155 Date25 Jan 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070155 decided 25 Jan 2007 Active
  • FDA GUDID UDI-DI 00850012724209 listed 18 Jul 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K070155
  2. Listed FDA GUDID 00850012724209

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Integrity
Generic name
Dental precision attachment fitting/adjustment tool
Model / reference
INT-E
Primary DI / UDI-DI
00850012724209
510(k) Number
FDA product code
EFB
GMDN term
Dental precision attachment fitting/adjustment tool
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Dental precision attachment fitting/adjustment tool.

Other devices from Osseo Scientific, LLC

  • Integrity NT-PG-III

    Class I
  • Integrity NTE-11

    Class I
  • Integrity NTS-14

    Class I
  • Integrity INT-SNC

    Class I

See all devices from Osseo Scientific, LLC →

Properties

  • Sterilise before use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)