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Kontact K30PP4

by Biotech Dental

Kontact K30PP4 is a Class II device made by Biotech Dental, cleared under FDA 510(k) K210220 on 18 Jun 2021 and listed in FDA GUDID since 1 Dec 2021 (UDI-DI 03701045236740), 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) K210220

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 Number03701045236740 UDI-DI Date1 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210220 Date18 Jun 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210220 decided 18 Jun 2021 Active
  • FDA GUDID UDI-DI 03701045236740 listed 1 Dec 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210220
  2. Listed FDA GUDID 03701045236740

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Kontact
Generic name
Dental implant system
Model / reference
K30PP4
Primary DI / UDI-DI
03701045236740
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

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)