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510(k) K230091

THE Cover by Purgo Biologics, Inc. — Product Code NPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2023
Date Received
January 12, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Barrier, Animal Source, Intraoral
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.

Other clearances by Purgo Biologics, Inc.

  • K230305 — THE Graft Collagen (July 24, 2024)
  • K222549 — OpenTex (May 11, 2023)
  • K191737 — The Graft Bone Substitute (February 14, 2020)
  • K180992 — Biotex (July 16, 2019)
  • K173188 — The Graft Natural Bone Substitute (July 20, 2018)

Other clearances for product code NPL

  • K242817 — Jason membrane (December 12, 2025)
  • K250512 — Augmented Gingival Matrix (December 5, 2025)
  • K252253 — Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® (November 25, 2025)
  • K251062 — Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; G (August 14, 2025)
  • K250833 — SwissMembrane X; SwissMembrane X Socket (April 15, 2025)
  • K233203 — Soft Tissue Augmentation Resorbable Matrix (May 1, 2024)
  • K231513 — Oral Matrix (February 16, 2024)
  • K231305 — Endoform Dental Membrane (January 23, 2024)
  • K223912 — InterCollagen® Guide (August 17, 2023)
  • K213904 — Kerecis Oral (September 30, 2022)