CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US
FDA 510(k) clearance K072643 · decided 2007-11-16
Clearance details
- K-number
- K072643
- Device name
- CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US
- Applicant
- Olympus Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-09-18
- Decision date
- 2007-11-16
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- KZN
- Device class
- 2
- Regulation number
- 872.3661
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CHROMASCAN TM (K770667) | Sterndent Corp. | 1977-04-20 |
Recalls involving this device
No recalls on record reference this clearance.