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Biotem AAAT50415B

by Biotem Co., ltd

Biotem AAAT50415B is a Class II device made by Biotem Co., ltd, cleared under FDA 510(k) K171297 on 31 Jan 2018 and listed in FDA GUDID since 31 May 2018 (UDI-DI 08800036212611), 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) K171297

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 Number08800036212611 UDI-DI Date31 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171297 Date31 Jan 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171297 decided 31 Jan 2018 Active
  • FDA GUDID UDI-DI 08800036212611 listed 31 May 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171297
  2. Listed FDA GUDID 08800036212611

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Biotem
Generic name
Dental implant system
Model / reference
AAAT50415B
Description
BIOTEM AR ANGLED ABUTMENT(HEX) 5.0mm Ⅹ 4mm(cuff) Ⅹ15'(angle)
Primary DI / UDI-DI
08800036212611
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
Radiation Sterilization

Related devices

Category: Dental implant system

Cleared under the same submission (K171297)

and 8 more cleared under K171297

Similar devices in this category

Other devices filed under Dental implant system.

Other devices from Biotem Co., ltd

See all devices from Biotem Co., ltd →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)