AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP— 510(k) K923539
Substantially EquivalentAmerican Dental Laser, Inc.
FDA 510(k) clearance K923539 for AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP, Substantially Equivalent on 1992-10-28. Applicant: American Dental Laser, Inc.. Device class: 2.
Clearance details
- Applicant
- American Dental Laser, Inc.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code GEX
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
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.