Skip to content

Angled abutment Regular Hex(A type) 333160

by BIO CONCEPT Co., Ltd.

Angled abutment Regular Hex(A type) 333160 is a Class II device made by BIO CONCEPT Co., Ltd., cleared under FDA 510(k) K192274 on 18 Jun 2020 and listed in FDA GUDID since 15 Jul 2020 (UDI-DI 06947600312260), active as of 22 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 22 Oct 2026

Documents

510(k) K192274

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06947600312260 UDI-DI Date15 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192274 Date18 Jun 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192274 decided 18 Jun 2020 Active
  • FDA GUDID UDI-DI 06947600312260 listed 15 Jul 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192274
  2. Listed FDA GUDID 06947600312260

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Angled abutment Regular Hex(A type)
Generic name
Dental implant system
Model / reference
333160
Primary DI / UDI-DI
06947600312260
510(k) Number
FDA product code
NHA
GMDN term
Dental implant system
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Dental implant system.

Other devices from BIO CONCEPT Co., Ltd.

See all devices from BIO CONCEPT Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)