Ace Surgical Supply Co., Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Ace Surgical Supply Co., Inc.” (first 1993, latest 2010), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 144 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 9 | 9 |
| EIA | Unit, Operative Dental | 4 | 4 |
| JEY | Plate, Bone | 3 | 3 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
| MQN | External Mandibular Fixator And/Or Distractor | 1 | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 | 1 |
Review panels
- Dental (20)
- General and Plastic Surgery (1)
Most recent Ace Surgical Supply Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093518 | ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM | DZE | 2010-01-14 | 62 |
| K092594 | ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX | DZE | 2009-09-16 | 23 |
| K073343 | ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX | DZE | 2008-03-13 | 106 |
| K080074 | ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX | DZE | 2008-02-14 | 34 |
| 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 | 2006-08-16 | 89 |
| K051381 | ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE | LYC | 2005-07-15 | 49 |
| K041759 | ACE CONNECT INTERNAL CONNECTION | DZE | 2004-07-22 | 23 |
| K021244 | ACE HA SCREW DENTAL IMPLANT SYSTEM | DZE | 2002-05-03 | 14 |
| K002075 | ACE SDS 3.75MM SCREW DENTAL IMPLANT | DZE | 2001-02-02 | 207 |
| K990140 | NORMED BONE TRANSPORT | JEY | 1999-03-25 | 65 |
11 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 4 recall events; 1 initiated in the last five years. Most recent: 2022-02-02.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ace Surgical Supply Co., Inc.?
FDA lists 21 510(k) clearances under the applicant name “Ace Surgical Supply Co., Inc.” (first 1993, latest 2010), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ace Surgical Supply Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ace Surgical Supply Co., Inc. is 144 days.
Which FDA product codes appear under Ace Surgical Supply Co., Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 9); EIA (Unit, Operative Dental, 4); JEY (Plate, Bone, 3).
Next steps
- See all 21 Ace Surgical Supply Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Ace Surgical Supply Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.