IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
FDA 510(k) clearance K963746 · decided 1996-12-12
Clearance details
- K-number
- K963746
- Device name
- IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
- Applicant
- Whitehill Oral Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-17
- Decision date
- 1996-12-12
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- JES
- Device class
- 1
- Regulation number
- 872.6390
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hazlet, NJ, 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 |
|---|---|---|
| CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS (K091964) | Procter & Gamble Co. | 2009-09-24 |
| FLOSSBRUSH WITH FLUORIDE (K964976) | Flossbrush Interdental Cleaner and Applicator | 1997-05-06 |
| PERIO-MED DENTAL FLOSS (K944034) | Whitehill Oral Technologies, Inc. | 1995-07-25 |
| VUTLER G.U.M. WITH FLUORIDE (K952091) | John O. Butler Co. | 1995-06-28 |
| JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS (K951917) | Johnson & Johnson Consumer Products, Inc. | 1995-05-10 |
| RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE (K942689) | Ranir/Dcp Corp. | 1995-04-27 |
| COLGATE PRECISION MINT WZXED DENTAL FLOSS (K944886) | Colgate-Palmolive Co. | 1995-04-27 |
| ORAL-B ULTRAFLOSS WITH FLLUORIDE (K943157) | Oral-B Laboratories | 1995-04-27 |
| RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (K942690) | Ranir/Dcp Corp. | 1995-04-27 |
| JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED (K935440) | Johnson & Johnson Consumer Products, Inc. | 1994-02-03 |
| RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE (K935522) | Ranir/Dcp Corp. | 1994-01-26 |
| FLOSS PLUS (K931353) | Floss Plus, Inc. | 1993-07-27 |
Recalls involving this device
No recalls on record reference this clearance.