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510(k) K840260

PERIOGRAF DURAPATITE 40-60 MESH by Sterling Drug, Inc. — Product Code LYC

K840260 is an FDA 510(k) premarket notification submitted by Sterling Drug, Inc. for the device "PERIOGRAF DURAPATITE 40-60 MESH". The FDA issued a decision of Substantially Equivalent on April 5, 1984. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Sterling Drug, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1984
Date Received
January 10, 1984
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)
  • K820023 — CONAGRAF TM DURAPATITE CONES (February 24, 1982)
  • K820164 — EMPTY STERILE CARPUJECT (February 24, 1982)
  • K813257 — ALVEOGRAF DURAPATITE(18-40 MESH) (January 5, 1982)
  • K813070 — PERIOGRAF (November 20, 1981)
  • K780209 — DILUTION SPIKE (April 10, 1978)

Other clearances for product code LYC

  • K253317 — Cytrans™ Elashield (July 6, 2026)
  • K253883 — Bonalive Maxillofacial (May 14, 2026)
  • 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)

FDA data resources