ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX— 510(k) K080074
Substantially EquivalentAce Surgical Supply Co., Inc.
FDA 510(k) clearance K080074 for ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX, Substantially Equivalent on 2008-02-14. Applicant: Ace Surgical Supply Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Ace Surgical Supply Co., Inc.
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Brockton, MA, US
Recent devices under product code DZE
view allMore clearances from Ace Surgical Supply Co., Inc.
view all- K093518 — ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
- K092594 — ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX
- K073343 — ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX
- 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
- K051381 — ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.