CARIES DETECTOR
FDA 510(k) clearance K012733 · decided 2001-09-14
Clearance details
- K-number
- K012733
- Device name
- CARIES DETECTOR
- Applicant
- Kuraray Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-14
- Decision date
- 2001-09-14
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- LFC
- Device class
- 2
- Regulation number
- 872.1740
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- New York, NY, US
- 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 |
|---|---|---|
| BlueCheck™ Caries Detection & Monitoring (K222560) | Incisive Technologies Pty, Ltd. | 2023-05-16 |
| LumiCare Caries Diagnostic Rinse (K200601) | GreenMark Biomedical, Inc. | 2021-03-29 |
| Vista Dyes (K193447) | Inter-Med/Vista Dental Products | 2020-03-11 |
| DISCOVRED (K102821) | Phoenix Dental, Inc. | 2011-03-11 |
| SEE-IT CARIES DETECTOR (K060330) | Ronvig Dental Mfg. A/S | 2006-04-07 |
| CARIES INDICATOR (K030807) | Confi-Dental Products Co. | 2003-06-09 |
| AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS (K994368) | American Dental Products, Inc. | 2000-03-14 |
| ORAL POTENTIAL METER (OPM) (K982105) | Pertec of Wisconsin, Inc. | 1998-09-16 |
| CARIES STAIN (K973200) | Parkell, Inc. | 1997-11-06 |
| PULPDENT SNOOP (K964430) | Pulpdent Corp. | 1997-01-17 |
| TEAM CARIES INDICATOR (K963927) | Centrix, Inc. | 1996-11-15 |
| CARIES FINDER (K955445) | Danville Engineering, Inc. | 1996-02-08 |
Recalls involving this device
No recalls on record reference this clearance.