OOLI-U(TONGUE SCRAPER)
FDA 510(k) clearance K970042 · decided 1997-03-14
Clearance details
- K-number
- K970042
- Device name
- OOLI-U(TONGUE SCRAPER)
- Applicant
- Telefax Intl.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-06
- Decision date
- 1997-03-14
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- LCN
- Device class
- 1
- Regulation number
- 872.6855
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lake Forest, CA, 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 |
|---|---|---|
| MIRACLEBREATH TONGUE CLEANER (K992270) | Stellar Labs, Inc. | 1999-09-23 |
| ORALGIENE TONGUE CLEANER (K990344) | Oralgiene USA, Inc. | 1999-05-04 |
| UNIK TONGUE CLEANER (K983683) | Unik Products, Inc. | 1999-01-14 |
| BREATHTIQUE TONGUE SCRAPER (K983087) | Custom Medical Arts, Inc. | 1998-11-18 |
| BREATHAID TONGUE SCRAPER (K981808) | Breathaid, LLC | 1998-08-11 |
| COPPER TONGUE SCRAPER (K980842) | Ontel Products Corp. | 1998-05-20 |
| CYBERSONIC (K980075) | American Dentronics, Inc. | 1998-03-04 |
| ENFRESH TONGUE BRUSH (K973424) | Enfresh Products, LLC | 1997-12-09 |
| TONGUE KLEAN (K973175) | Softek Ent. | 1997-10-14 |
| BREATH-SO-FRESH TONGUE CLEANER (K972644) | Intl. Dental Design Specialists, Inc. | 1997-09-11 |
| BREATH ACE BREATHFRESHENER (K972131) | Beyond 21st Century, Inc. | 1997-07-18 |
| BREATH TAKER (K971887) | Hofa, LLC | 1997-06-10 |
Recalls involving this device
No recalls on record reference this clearance.