510(k) Report

FDA applicant

Ace Surgical Supply Co., Inc.

Brockton, MA23 decisions1993–20113 recalls

FDA records 23 decisions for Ace Surgical Supply Co., Inc. (Brockton, MA) from 1993 to 2011: 23 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and EIA (Unit, Operative Dental). Its devices cite 18 predicates, 10 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Ace Surgical Supply Company, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Ace Surgical Supply Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 22009: 12010: 22011: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2010: 22017: 1
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ace Surgical Supply Co., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ace Surgical Supply Co., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form11decisions
  • EIAUnit, Operative Dental4decisions
  • JEYPlate, Bone3decisions
  • DZLScrew, Fixation, Intraosseous1decision
  • LYCBone Grafting Material, Synthetic1decision
  • LROGeneral Surgery Tray1decision

Also: MQN (1), OAT (1).

Whose devices does it build on?

Its devices cite 18 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K951392Miniboneplate SystemAce Surgical Supply Co., Inc. · 19954cite it
  • K954513Ace Srew Dentla Implant SystemAce Surgical Supply Co., Inc. · 19964cite it
  • K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc. · 20093cite it
  • K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc. · 20083cite it
  • K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 20082cite it
  • K951510Ace Bone Screw Tacking KitAce Surgical Supply Co., Inc. · 19951cites it

What has FDA decided for it lately?

  • K103790Ace Trimark Tricam Dental ImplantAce Surgical Supply Company, Inc. · 2011
  • K102981Ace Freedom Internal Hexagon Dental Implant SystemAce Surgical Supply Company, Inc. · 2010
  • K093518Ace Surgical Secure Locator 3.25 Implant SystemAce Surgical Supply Co., Inc. · 20101 recall
  • K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc. · 2009
  • K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 2008
  • K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc. · 2008
  • K061397Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model 454-91001,454-91002 and 1.2/1.5MM X…Ace Surgical Supply Co., Inc. · 2006
  • K051381Ace Surgicalplaster Calcium Sulface HemihydrateAce Surgical Supply Co., Inc. · 20052 recalls

All 21 as Ace Surgical Supply Co., Inc. →All 2 as Ace Surgical Supply Company, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K093518INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight…Feb 22, 2017Class II
  • K051381Calcium Sulfate Hemihydrate 0.5 gram kits.May 14, 2010
  • K051381Calcium Sulfate Hemihydrate 1.0 gram kits.May 14, 2010