ACE ALVEOLAR DISTRACTOR— 510(k) K981526
Substantially EquivalentAce Surgical Supply Co., Inc.
FDA 510(k) clearance K981526 for ACE ALVEOLAR DISTRACTOR, Substantially Equivalent on 1998-11-06. Applicant: Ace Surgical Supply Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Ace Surgical Supply Co., Inc.
- Product code
- Code JEY
- Device class
- Class 2
- Regulation
- 21 CFR 872.4760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brockton, MA, US
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More clearances from Ace Surgical Supply Co., Inc.
view all- K093518 — ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
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- 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
Adverse events under product code JEY
product code JEY- Injury
- 1,542
- Malfunction
- 2,292
- Total
- 3,834
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.