|
Device | CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM |
Generic Name | SOLUTION, REMOVAL, CARRIES |
Applicant | RLS GLOBAL AB Neongatan 5 Molndal S-431-431- |
PMA Number | P000005 |
Date Received | 01/10/2000 |
Decision Date | 06/27/2001 |
Withdrawal Date
|
06/09/2022 |
Product Code |
LMW |
Docket Number | 01M-0337 |
Notice Date | 08/13/2001 |
Advisory Committee |
Dental |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 S005 |