LCN · Scraper, Tongue
Dental · 21 CFR 872.6855 · Class 1
Overview
| Product Code | LCN |
|---|---|
| Device Name | Scraper, Tongue |
| Regulation | 21 CFR 872.6855 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992270 | MIRACLEBREATH TONGUE CLEANER | Stellar Labs, Inc. | Sep 23, 1999 | SESE |
| K990344 | ORALGIENE TONGUE CLEANER | Oralgiene USA, Inc. | May 4, 1999 | SESE |
| K983683 | UNIK TONGUE CLEANER | Unik Products, Inc. | Jan 14, 1999 | SESE |
| K983087 | BREATHTIQUE TONGUE SCRAPER | Custom Medical Arts, Inc. | Nov 18, 1998 | SESE |
| K981808 | BREATHAID TONGUE SCRAPER | Breathaid, LLC | Aug 11, 1998 | SESE |
| K980842 | COPPER TONGUE SCRAPER | Ontel Products Corp. | May 20, 1998 | SESE |
| K980075 | CYBERSONIC | American Dentronics, Inc. | Mar 4, 1998 | SESE |
| K973424 | ENFRESH TONGUE BRUSH | Enfresh Products, LLC | Dec 9, 1997 | SESE |
| K973175 | TONGUE KLEAN | Softek Ent. | Oct 14, 1997 | SESE |
| K972644 | BREATH-SO-FRESH TONGUE CLEANER | Intl. Dental Design Specialists, Inc. | Sep 11, 1997 | SESE |
| K972131 | BREATH ACE BREATHFRESHENER | Beyond 21st Century, Inc. | Jul 18, 1997 | SESE |
| K971887 | BREATH TAKER | Hofa, LLC | Jun 10, 1997 | SESE |
| K971025 | AYURVEDIC TONGUE CLEANER | Calello Martinez P.C. | May 22, 1997 | SESE |
| K970042 | OOLI-U(TONGUE SCRAPER) | Telefax Intl. | Mar 14, 1997 | SESE |
| K962941 | OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE | Deep Trading Corp. | Oct 8, 1996 | SESE |
| K961574 | TONGUE SCRAPPER | U.S. Dentek Corp. | Jun 10, 1996 | SESE |
| K961660 | TONGUE CLEANER | Jack Conrey | May 31, 1996 | SESE |
| K952446 | TONGUE CLEAN | 1-800-Tongues, Inc. | Jun 22, 1995 | SESE |
| K942076 | TONGUE SCRAPER | Maharishi Ayur-Ved | Aug 23, 1994 | SESE |
| K932839 | A MANO TONGUE CLEANSER | A Mano Products, Ltd. | Sep 23, 1993 | SESE |
Top Applicants
- Arkay Co. — 2 clearances
- Unik Products, Inc. — 1 clearance
- U.S. Dentek Corp. — 1 clearance
- Telefax Intl. — 1 clearance
- Stellar Labs, Inc. — 1 clearance
