Ace Surgical Supply Co., Inc.
Brockton, MA, US
Ace Surgical Supply Co., Inc. appears in FDA device records in Brockton, MA. FDA records list 23 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Ace Surgical Supply Co., Inc. between 1993 and 2011. The busiest year on record is 1994, with 4. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 4 |
| 1995 | 2 |
| 1996 | 3 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103790 | ACE TRIMARK TRICAM DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K102981 | ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K093518 | ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K092594 | ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX | DZE | Substantially Equivalent | |
| K073343 | ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX | DZE | Substantially Equivalent | |
| K080074 | ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX | DZE | Substantially Equivalent | |
| K061397 | ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M | OAT | Substantially Equivalent | |
| K051381 | ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE | LYC | Substantially Equivalent | |
| K041759 | ACE CONNECT INTERNAL CONNECTION | DZE | Substantially Equivalent | |
| K021244 | ACE HA SCREW DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K002075 | ACE SDS 3.75MM SCREW DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K990140 | NORMED BONE TRANSPORT | JEY | Substantially Equivalent | |
| K981526 | ACE ALVEOLAR DISTRACTOR | JEY | Substantially Equivalent | |
| K954605 | ACE CYLINDER DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K954513 | ACE SREW DENTLA IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K952847 | NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR | MQN | Substantially Equivalent | |
| K951510 | ACE BONE SCREW TACKING KIT | DZL | Substantially Equivalent | |
| K951392 | MINIBONEPLATE SYSTEM | JEY | Substantially Equivalent | |
| K922652 | ACE BASIC DENTAL IMPLANT PACK I | EIA | Substantially Equivalent | |
| K922651 | ACE DENTAL IMPLANT KIT | EIA | Substantially Equivalent | |
| K922650 | ACE DENTAL IMPLANT CUSTOM SURGICAL PACK | EIA | Substantially Equivalent | |
| K922649 | ACE BASIC DENTAL IMPLANT PACK II | EIA | Substantially Equivalent | |
| K922648 | ACE CUSTOM SURGICAL PACK | LRO | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0823-2022 | NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250 | NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair | Class II | Open, Classified | |
| Z-1464-2018 | Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity. | The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade. | Class II | Terminated | |
| Z-1835-2017 | INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment. | Incorrect device was packaged. | Class II | Terminated | |
| Z-1806-2010 | Calcium Sulfate Hemihydrate 1.0 gram kits. | 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. | Terminated | ||
| Z-1805-2010 | Calcium Sulfate Hemihydrate 0.5 gram kits. | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain