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510(k) K051381

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

K051381 is an FDA 510(k) premarket notification submitted by Ace Surgical Supply Co., Inc. for the device "ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE". The FDA issued a decision of Substantially Equivalent on July 15, 2005. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Ace Surgical Supply Co., Inc. has at least 10 other 510(k) clearances on record.

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

  • 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