Ace Surgical Supply Co., Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 21
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0823-2022 | Class II | NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. C | February 2, 2022 |
| Z-1464-2018 | Class II | Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft i | March 28, 2018 |
| D-0071-2018 | Class II | Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc | October 24, 2017 |
| Z-1835-2017 | Class II | INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 2014 | February 22, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| 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, 09-2705-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 454-91001,454-91002 AND 1.2 | August 16, 2006 |
| K051381 | ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE | July 15, 2005 |
| 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 |
| K954605 | ACE CYLINDER DENTAL IMPLANT | June 5, 1996 |
| K954513 | ACE SREW DENTLA IMPLANT SYSTEM | June 5, 1996 |
| K952847 | NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR | February 6, 1996 |
| K951510 | ACE BONE SCREW TACKING KIT | August 25, 1995 |
| K951392 | MINIBONEPLATE SYSTEM | May 5, 1995 |
| K922650 | ACE DENTAL IMPLANT CUSTOM SURGICAL PACK | January 10, 1994 |
| K922649 | ACE BASIC DENTAL IMPLANT PACK II | January 10, 1994 |
| K922651 | ACE DENTAL IMPLANT KIT | January 10, 1994 |
| K922652 | ACE BASIC DENTAL IMPLANT PACK I | January 10, 1994 |