IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
FDA 510(k) clearance K991996 · decided 1999-09-08
Clearance details
- K-number
- K991996
- Device name
- IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
- Applicant
- Denplus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-14
- Decision date
- 1999-09-08
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Montreal, Quebec, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.