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510(k) K223912

InterCollagen® Guide by Sigmagraft, Inc. — Product Code NPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2023
Date Received
December 29, 2022
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 Sigmagraft, Inc.

  • K221808 — InterOss Collagen (March 18, 2023)
  • K151209 — InterOss (November 6, 2015)

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