510(k) K051381

ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE by Ace Surgical Supply Co., Inc. — Product Code LYC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 15, 2005
Date Received: May 27, 2005
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 Ace Surgical Supply Co., Inc.

K093518 — ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM (January 14, 2010)
K092594 — ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, (September 16, 2009)
K073343 — ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX (March 13, 2008)
K080074 — ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX (February 14, 2008)
K061397 — ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-910 (August 16, 2006)
K041759 — ACE CONNECT INTERNAL CONNECTION (July 22, 2004)
K021244 — ACE HA SCREW DENTAL IMPLANT SYSTEM (May 3, 2002)
K002075 — ACE SDS 3.75MM SCREW DENTAL IMPLANT (February 2, 2001)
K990140 — NORMED BONE TRANSPORT (March 25, 1999)
K981526 — ACE ALVEOLAR DISTRACTOR (November 6, 1998)

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)