FLEXITIME BITE— 510(k) K082591
Substantially EquivalentHeraeus Kulzer, Inc., Dental Products Division
FDA 510(k) clearance K082591 for FLEXITIME BITE, Substantially Equivalent on 2008-12-05. Applicant: Heraeus Kulzer, Inc., Dental Products Division. Device class: 2.
Clearance details
- Applicant
- Heraeus Kulzer, Inc., Dental Products Division
- 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
- South Bend, IN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.