CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM
FDA premarket approval P000005 · decided 2001-06-27
Approval details
- PMA number
- P000005
- Trade name
- CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM
- Generic name
- SOLUTION, REMOVAL, CARRIES
- Applicant
- Rls Global AB
- Date received
- 2000-01-10
- Decision date
- 2001-06-27
- Days to decision
- 534 days
- Decision code
- APWD
- Product code
- LMW
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Molndal
- Statement
- APPROVAL FOR THE CARISOLV(TM) NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM. THE DEVICE IS INTENDED FOR THE CHEMO-MECHANICAL SOFTENING AND REMOVAL OF DENTIN CARIES WHEN USED IN CONJUNCTION WITH A DENTAL HANDPIECE.
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