DENTISCOPE
FDA 510(k) clearance K820907 · decided 1982-05-05
Clearance details
- K-number
- K820907
- Device name
- DENTISCOPE
- Applicant
- Chayes Virginia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-01
- Decision date
- 1982-05-05
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- EAY
- Device class
- 1
- Regulation number
- 872.4620
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| MODEL A15-101 (K953191) | Beaverstate Dental, Inc. | 1995-09-05 |
| MODEL A15-103 (K953192) | Beaverstate Dental, Inc. | 1995-09-05 |
| JEDENTAL VLC DENTAL CURING LIGHT (K935718) | Jedental Co., Inc. | 1994-01-26 |
| STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM (K871816) | Stryker Corp. | 1987-08-03 |
| POWER OPTIC (K831976) | Ritter Co. | 1983-08-12 |
| DENTAL ELECTRONIC/S.B.R TRADING BU HAND (K831824) | Silverman'S | 1983-08-11 |
| FIBER OPTIC LIGHT SOURCE I (K812605) | Venture Technology, Inc. | 1981-10-02 |
| HELIOMAT (K802684) | Vivadent (Usa), Inc. | 1980-11-24 |
| DEN-MAT FIBER OPTIC HALOGEN LIGHT (K802716) | Den-Mat Corp. | 1980-11-12 |
| FIBER OPTIC HOSE (K801592) | Lares Manufacturing Co., Inc. | 1980-07-21 |
| FIBER OPTIC ILLUMINATOR (K801591) | Lares Manufacturing Co., Inc. | 1980-07-21 |
| ORALUMINATOR III AUTO-LIGHT (K791771) | Midwest | 1979-11-20 |
Recalls involving this device
No recalls on record reference this clearance.