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— 510(k) K061397
Substantially EquivalentAce Surgical Supply Co., Inc.
FDA 510(k) clearance K061397 for 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, Substantially Equivalent on 2006-08-16. Applicant: Ace Surgical Supply Co., Inc..
Clearance details
- Applicant
- Ace Surgical Supply Co., Inc.
- Product code
- Code OAT
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brockton, MA, US
Adverse events under product code OAT
product code OAT- Injury
- 355
- Total
- 355
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.