ISOSIT TEETH— 510(k) K810970
Substantially EquivalentBauer, Cheng & Associates, Inc.
FDA 510(k) clearance K810970 for ISOSIT TEETH, Substantially Equivalent on 1981-05-05. Applicant: Bauer, Cheng & Associates, Inc.. Device class: 2.
Clearance details
- Applicant
- Bauer, Cheng & Associates, Inc.
- Product code
- Code ELM
- Device class
- Class 2
- Regulation
- 21 CFR 872.3590
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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