Electronic Caries Detector— 510(k) K170822
Substantially EquivalentOrtek Therapeutics, Inc.
FDA 510(k) clearance K170822 for Electronic Caries Detector, Substantially Equivalent on 2017-09-11. Applicant: Ortek Therapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortek Therapeutics, Inc.
- Product code
- Code NBL
- Device class
- Class 2
- Regulation
- 21 CFR 872.1745
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roslyn Heights, NY, US
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