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Cytoflex Resorb 12x24mm

by Unicare Biomedical, Inc.

Cytoflex Resorb 12x24mm (C03-0301) is a Class II device made by Unicare Biomedical, Inc., cleared under FDA 510(k) K090083 on 23 Mar 2009 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI D767C0303010), 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) K090083

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 NumberD767C0303010 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090083 Date23 Mar 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090083 decided 23 Mar 2009 Active
  • FDA GUDID UDI-DI D767C0303010 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090083
  2. Listed FDA GUDID D767C0303010

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cytoflex Resorb
Generic name
Pliable-polymer dental regeneration membrane, bioabsorbable, ligated
Model / Ref / Catalog
12x24mm, C03-0301
Primary DI / UDI-DI
D767C0303010
510(k) Number
FDA product code
NPK
GMDN term
Pliable-polymer dental regeneration membrane, bioabsorbable, ligated
Device class
Class II
Regulation number
872.3930
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pliable-polymer dental regeneration membrane, bioabsorbable, ligated

Cleared under the same submission (K090083)

Similar devices

Other devices filed under FDA product code NPK (Barrier, Synthetic, Intraoral).

Other devices from Unicare Biomedical, Inc.

See all devices from Unicare Biomedical, Inc. →

Properties

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