KROMALGIN IMPRESSION MATERIAL— 510(k) K964177
Substantially EquivalentNorth American Orthodontic Laboratories, Inc.
FDA 510(k) clearance K964177 for KROMALGIN IMPRESSION MATERIAL, Substantially Equivalent on 1996-12-30. Applicant: North American Orthodontic Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- North American Orthodontic Laboratories, Inc.
- Product code
- Code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gainsville, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.