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Geistlich Bio-Gide® 502113

by Geistlich Pharma AG

Geistlich Bio-Gide® 502113 is a Class II device made by Geistlich Pharma AG, cleared under FDA 510(k) K251062 on 14 Aug 2025 and listed in FDA GUDID since 9 Apr 2026 (UDI-DI 07610221017201), 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) K251062

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 Number07610221017201 UDI-DI Date9 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251062 Date14 Aug 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251062 decided 14 Aug 2025 Active
  • FDA GUDID UDI-DI 07610221017201 listed 9 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251062
  2. Listed FDA GUDID 07610221017201

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Geistlich Bio-Gide®
Generic name
Collagen dental regeneration membrane
Model / reference
502113
Primary DI / UDI-DI
07610221017201
510(k) Number
FDA product code
NPL
GMDN term
Collagen dental regeneration membrane
Device class
Class II
Regulation number
872.3930
GUDID distribution status
In Commercial Distribution
Size
Width — 16 Millimeter
Height — 22 Millimeter

Related devices

Cleared under the same submission (K251062)

Similar devices

Other devices filed under FDA product code NPL (Barrier, Animal Source, Intraoral).

Other devices from Geistlich Pharma AG

See all devices from Geistlich Pharma AG →

Properties

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