Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ace Surgical Supply Co., Inc. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
144 daysmedian FDA review time
586 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093518 | ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM | Ace Surgical Supply Co., Inc. | 2010-01-14 | 62 | 1 |
| K092594 | ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2 | Ace Surgical Supply Co., Inc. | 2009-09-16 | 23 | 0 |
| K073343 | ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX | Ace Surgical Supply Co., Inc. | 2008-03-13 | 106 | 0 |
| K080074 | ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX | Ace Surgical Supply Co., Inc. | 2008-02-14 | 34 | 0 |
| K061397 | ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6M | Ace Surgical Supply Co., Inc. | 2006-08-16 | 89 | 0 |
| K051381 | ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE | Ace Surgical Supply Co., Inc. | 2005-07-15 | 49 | 2 |
| K041759 | ACE CONNECT INTERNAL CONNECTION | Ace Surgical Supply Co., Inc. | 2004-07-22 | 23 | 0 |
| K021244 | ACE HA SCREW DENTAL IMPLANT SYSTEM | Ace Surgical Supply Co., Inc. | 2002-05-03 | 14 | 0 |
| K002075 | ACE SDS 3.75MM SCREW DENTAL IMPLANT | Ace Surgical Supply Co., Inc. | 2001-02-02 | 207 | 0 |
| K990140 | NORMED BONE TRANSPORT | Ace Surgical Supply Co., Inc. | 1999-03-25 | 65 | 0 |
| K981526 | ACE ALVEOLAR DISTRACTOR | Ace Surgical Supply Co., Inc. | 1998-11-06 | 192 | 0 |
| K954513 | ACE SREW DENTLA IMPLANT SYSTEM | Ace Surgical Supply Co., Inc. | 1996-06-05 | 251 | 0 |
| K954605 | ACE CYLINDER DENTAL IMPLANT | Ace Surgical Supply Co., Inc. | 1996-06-05 | 245 | 0 |
| K952847 | NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR | Ace Surgical Supply Co., Inc. | 1996-02-06 | 230 | 0 |
| K951510 | ACE BONE SCREW TACKING KIT | Ace Surgical Supply Co., Inc. | 1995-08-25 | 144 | 0 |
| K951392 | MINIBONEPLATE SYSTEM | Ace Surgical Supply Co., Inc. | 1995-05-05 | 45 | 0 |
| K922652 | ACE BASIC DENTAL IMPLANT PACK I | Ace Surgical Supply Co., Inc. | 1994-01-10 | 586 | 0 |
| K922651 | ACE DENTAL IMPLANT KIT | Ace Surgical Supply Co., Inc. | 1994-01-10 | 586 | 0 |
| K922649 | ACE BASIC DENTAL IMPLANT PACK II | Ace Surgical Supply Co., Inc. | 1994-01-10 | 586 | 0 |
| K922650 | ACE DENTAL IMPLANT CUSTOM SURGICAL PACK | Ace Surgical Supply Co., Inc. | 1994-01-10 | 586 | 0 |
| K922648 | ACE CUSTOM SURGICAL PACK | Ace Surgical Supply Co., Inc. | 1993-03-20 | 290 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda