LOGICON CARIES DETECTOR
FDA premarket approval P980025/S003 · decided 2015-12-10
Approval details
- PMA number
- P980025
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LOGICON CARIES DETECTOR
- Generic name
- Analyzer, medical image
- Applicant
- Carestream Dental, LLC
- Date received
- 2015-10-23
- Decision date
- 2015-12-10
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Atlanta, GA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT CARESTREAM DENTAL IN ATLANTA, GEORGIA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE (K122427) | Carestream Dental, LLC | 2012-09-12 |