510(k) K813070

PERIOGRAF by Sterling Drug, Inc. — Product Code LYC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 20, 1981
Date Received: November 2, 1981
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bone Grafting Material, Synthetic
Device Class: Class II
Regulation Number: 872.3930
Review Panel: DE
Submission Type

A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.

Other clearances by Sterling Drug, Inc.

K901369 — GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II (June 5, 1990)
K896110 — BIOBRANE(R) II (November 28, 1989)
K875275 — WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER (January 27, 1988)
K840260 — PERIOGRAF DURAPATITE 40-60 MESH (April 5, 1984)
K820023 — CONAGRAF TM DURAPATITE CONES (February 24, 1982)
K820164 — EMPTY STERILE CARPUJECT (February 24, 1982)
K813257 — ALVEOGRAF DURAPATITE(18-40 MESH) (January 5, 1982)
K780209 — DILUTION SPIKE (April 10, 1978)

Other clearances for product code LYC

K251818 — BONTREE PLUS (March 6, 2026)
K244006 — FG Bone Graft M (September 17, 2025)
K243745 — FG Bone Graft B (August 29, 2025)
K241186 — Synthetic Bone Graft Particulate (February 21, 2025)
K213260 — CMFlexTM (December 30, 2022)
K202675 — InRoad® Dental Synthetic Bone Graft (March 4, 2022)
K201546 — OsOpia Synthetic Bone Void Filler (October 2, 2020)
K201051 — Straumann BoneCeramic (September 24, 2020)
K192597 — Cytrans Granules (August 17, 2020)
K153676 — OSTEON III (September 14, 2016)