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Sign in to claim this brandACE SURGICAL SUPPLY CO., INC.
US
Last updated May 24, 2026
What ACE SURGICAL SUPPLY CO., INC. makes
ACE Surgical Supply Co., Inc. manufactures dental implants and related components, including one-piece endosteal screw implants, permanent and temporary preformed suprastructures, and animal-derived bone matrix implants for grafting. Their portfolio also includes reusable surgical tools like carbide dental burs, osteotomes, retractors, and soft-tissue manipulation forceps designed for dental procedures.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does ACE Surgical Supply Co., Inc. primarily manufacture?
ACE Surgical Supply Co., Inc. specializes in dental devices, including endosteal screw implants (one-piece), permanent and temporary preformed suprastructures for implants, and bone matrix implants derived from animal sources for grafting. They also produce reusable surgical tools like carbide dental burs, osteotomes, retractors, and forceps for soft-tissue manipulation, all designed for dental procedures.
Where is ACE Surgical Supply Co., Inc. based, and does this location affect its regulatory compliance?
The company is based in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since the U.S. has strict medical device regulations, the manufacturer ensures its products meet applicable standards for safety, performance, and labeling before entering the market.
Which regulatory registries or databases list ACE Surgical Supply Co., Inc.’s devices?
ACE Surgical Supply Co., Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain and regulatory oversight.
How are ACE Surgical Supply Co., Inc.’s devices classified under FDA regulations?
The company’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and regulatory history.
What does it mean for ACE Surgical Supply Co., Inc.’s devices to be listed in the FDA’s UDI database?
Listing in the FDA’s UDI database means each device has a unique identifier (UDI) that includes a device identifier and a production identifier. This system improves device tracking, reduces medical errors, and enhances transparency in the healthcare supply chain. It also helps regulators and healthcare providers verify product authenticity and recall information when needed.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- acesurgical.com
- —
- —
- [email protected]
- Phone
- +1(508)588-3100
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 042763706
Catalogue (2744)
Page 2 of 55| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TRICAM Dental Implant System | 30150523 | FDA UDI | Class II | Active |
| Infinity | 20161001 | FDA UDI | Class I | Active |
| miniMark Dental Implant System | 10231140 | FDA UDI | Class II | Active |
| Ace | 0112330 | FDA UDI | Class I | Active |
| Ace | 0900023 | FDA UDI | Class I | Active |
| Ace | 64441903 | FDA UDI | Class I | Active |
| Ace | 31680031ST | FDA UDI | Class I | Active |
| Ace | 3105206 | FDA UDI | Class I | Active |
| Ace | 6400214 | FDA UDI | Class I | Active |
| Ace | 1000031 | FDA UDI | Class I | Active |
| Ace | 0034236 | FDA UDI | Class I | Active |
| Ace | 04942002 | FDA UDI | Class I | Active |
| Ace | 12705001 | FDA UDI | Class I | Active |
| Ace | 04957701 | FDA UDI | Class I | Active |
| Ace | 0800020 | FDA UDI | Class I | Active |
| Infinity External Hex Implant System | 404708 | FDA UDI | Class II | Active |
| Ace | 4546701 | FDA UDI | Class I | Active |
| Ace | 0030993 | FDA UDI | Class I | Active |
| Ace | 6614003 | FDA UDI | Class I | Active |
| Ace | 01404813 | FDA UDI | Class II | Active |
| Infinty External Hex System | 50MUA23 | FDA UDI | Class II | Active |
| Ace | 6300452 | FDA UDI | Class I | Active |
| Ace | 0038212 | FDA UDI | Class I | Active |
| Ace | 0039429 | FDA UDI | Class II | Active |
| Internal Hex | 20450001 | FDA UDI | Class II | Active |
| REGENX PuraXEN | PGAB05 | FDA UDI | Class II | Active |
| MinerOss® X | BH0022 | FDA UDI | Class II | Unknown |
| Hexagon | 1312024 | FDA UDI | Class II | Active |
| Infinity External Hex Implant System | 403310 | FDA UDI | Class II | Active |
| Infinity Internal Hex System | 20135375 | FDA UDI | Class II | Active |
| Ace | 04973301 | FDA UDI | Class II | Active |
| TRUFIX Bone Fixation System | 45491704 | FDA UDI | Class II | Active |
| Infinity External Hex System | 01409212 | FDA UDI | Class II | Active |
| Ace | 04954502 | FDA UDI | Class I | Active |
| miniMark Dental Implant System | 10321305 | FDA UDI | Class II | Active |
| Ace | 0039436 | FDA UDI | Class II | Active |
| Hexagon | 1312063 | FDA UDI | Class II | Active |
| Ace | 0034241 | FDA UDI | Class I | Active |
| Infinty External Hex System | 2035MU17 | FDA UDI | Class II | Active |
| OUSIA bioXEN | OUSM2S | FDA UDI | Class II | Active |
| Ace | 2002002 | FDA UDI | Class I | Active |
| Ace | 6300421 | FDA UDI | Class I | Active |
| Ace | 1000022 | FDA UDI | Class I | Active |
| Ace | 0100107 | FDA UDI | Class I | Active |
| Infinity Internal Hex System | 204108 | FDA UDI | Class II | Active |
| Ace | 0613048 | FDA UDI | Class I | Active |
| Ace | 0112331 | FDA UDI | Class I | Active |
| Ace | 31590031ST | FDA UDI | Class I | Active |
| Ace | 4542801 | FDA UDI | Class I | Active |
| Ace | 31310023 | FDA UDI | Class I | Active |
Related Companies
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FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
ACE Surgical Supply Co., Inc. has five recall records initiated between May 14, 2010, and February 2, 2022. The records include instances where incorrect components were packaged—such as a single blade instead of a double blade, a non-sterile Fast Set 4% potassium sulfate solution, and a Collatene Fibrillar Collagen block mistakenly included with a NuOss Collagen dental product. The recalls are marked as open, classified, or terminated, with no additional details on outcomes provided.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 2, 2022 | Z-0823-2022 | — | open, classified | NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair |
| Mar 28, 2018 | Z-1464-2018 | — | terminated | The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade. |
| Feb 22, 2017 | Z-1835-2017 | — | terminated | Incorrect device was packaged. |
| May 14, 2010 | Z-1805-2010 | — | terminated | Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risks identified do not apply. Risks of adverse health consequences with the Fast Set 4% potassium sulfate solution include tissue inflammation and infection. |
| May 14, 2010 | Z-1806-2010 | — | terminated | Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risks identified do not apply. Risks of adverse health consequences with the Fast Set 4% potassium sulfate solution include tissue inflammation and infection. |