ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM— 510(k) K093518
Substantially EquivalentAce Surgical Supply Co., Inc.
FDA 510(k) clearance K093518 for ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM, Substantially Equivalent on 2010-01-14. 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- 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
- K080074 — ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-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 →
Recalls naming K093518
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093518.
Data sourced from openFDA. This site is unofficial and independent of the FDA.