Company ยท US
Ace Surgical Supply Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2011. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 12 |
| EIA | Unit, Operative Dental | 4 |
| JEY | Plate, Bone | 3 |
| LYC | Bone Grafting Material, Synthetic | 3 |
| DZL | Screw, Fixation, Intraosseous | 1 |
| EMO | Knife, Periodontic | 1 |
| LRO | General Surgery Tray | 1 |
| MQN | External Mandibular Fixator And/Or Distractor | 1 |
| NPM | Bone Grafting Material, Animal Source | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 18, 2011 | K103790 | ACE TRIMARK TRICAM DENTAL IMPLANT Ace Surgical Supply Company, Inc. | DZE |
| Dec 20, 2010 | K102981 | ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM Ace Surgical Supply Company, Inc. | DZE |
| Jan 14, 2010 | K093518 | ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM Ace Surgical Supply Co., Inc. | DZE |
| Sep 16, 2009 | K092594 | ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX Ace Surgical Supply Co., Inc. | DZE |
| Mar 13, 2008 | K073343 | ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX Ace Surgical Supply Co., Inc. | DZE |
| Feb 14, 2008 | K080074 | ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX Ace Surgical Supply Co., Inc. | DZE |
| Aug 16, 2006 | 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 Ace Surgical Supply Co., Inc. | OAT |
| Jul 15, 2005 | K051381 | ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE Ace Surgical Supply Co., Inc. | LYC |
| Jul 22, 2004 | K041759 | ACE CONNECT INTERNAL CONNECTION Ace Surgical Supply Co., Inc. | DZE |
| May 3, 2002 | K021244 | ACE HA SCREW DENTAL IMPLANT SYSTEM Ace Surgical Supply Co., Inc. | DZE |
| Feb 2, 2001 | K002075 | ACE SDS 3.75MM SCREW DENTAL IMPLANT Ace Surgical Supply Co., Inc. | DZE |
| Mar 25, 1999 | K990140 | NORMED BONE TRANSPORT Ace Surgical Supply Co., Inc. | JEY |
| Nov 6, 1998 | K981526 | ACE ALVEOLAR DISTRACTOR Ace Surgical Supply Co., Inc. | JEY |
| Jun 5, 1996 | K954605 | ACE CYLINDER DENTAL IMPLANT Ace Surgical Supply Co., Inc. | DZE |
| Jun 5, 1996 | K954513 | ACE SREW DENTLA IMPLANT SYSTEM Ace Surgical Supply Co., Inc. | DZE |
| Feb 6, 1996 | K952847 | NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR Ace Surgical Supply Co., Inc. | MQN |
| Aug 25, 1995 | K951510 | ACE BONE SCREW TACKING KIT Ace Surgical Supply Co., Inc. | DZL |
| May 5, 1995 | K951392 | MINIBONEPLATE SYSTEM Ace Surgical Supply Co., Inc. | JEY |
| Jan 10, 1994 | K922652 | ACE BASIC DENTAL IMPLANT PACK I Ace Surgical Supply Co., Inc. | EIA |
| Jan 10, 1994 | K922651 | ACE DENTAL IMPLANT KIT Ace Surgical Supply Co., Inc. | EIA |
| Jan 10, 1994 | K922650 | ACE DENTAL IMPLANT CUSTOM SURGICAL PACK Ace Surgical Supply Co., Inc. | EIA |
| Jan 10, 1994 | K922649 | ACE BASIC DENTAL IMPLANT PACK II Ace Surgical Supply Co., Inc. | EIA |
| Mar 20, 1993 | K922648 | ACE CUSTOM SURGICAL PACK Ace Surgical Supply Co., Inc. | LRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2022 | Ace Surgical Supply Co., Inc. NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects.
Catalog Number: 5099250 Open, Classified |
NPM | K043034 |
| Mar 28, 2018 | Ace Surgical Supply Co., Inc. Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009
Used to achieve epithelial graft in the oral cavity. Terminated |
EMO | None listed |
| Apr 17, 2017 | Ace Surgical Supply Co., Inc. INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473
Product Usage:
Non implantable dental abutment. Terminated |
DZE | K093518 |
| Jun 16, 2010 | Ace Surgical Supply Co., Inc. Calcium Sulfate Hemihydrate 1.0 gram kits. Terminated |
LYC | K051381 |
| Jun 16, 2010 | Ace Surgical Supply Co., Inc. Calcium Sulfate Hemihydrate 0.5 gram kits. Terminated |
LYC | K051381 |