MILLENNIUM
FDA 510(k) clearance K980585 · decided 1998-10-08
Clearance details
- K-number
- K980585
- Device name
- MILLENNIUM
- Applicant
- Biolase Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-17
- Decision date
- 1998-10-08
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.