Product code LCN
- Device name
- Scraper, Tongue
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6855
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992270 | MIRACLEBREATH TONGUE CLEANER | Stellar Labs, Inc. | 1999-09-23 |
| K990344 | ORALGIENE TONGUE CLEANER | Oralgiene USA, Inc. | 1999-05-04 |
| K983683 | UNIK TONGUE CLEANER | Unik Products, Inc. | 1999-01-14 |
| K983087 | BREATHTIQUE TONGUE SCRAPER | Custom Medical Arts, Inc. | 1998-11-18 |
| K981808 | BREATHAID TONGUE SCRAPER | Breathaid, LLC | 1998-08-11 |
| K980842 | COPPER TONGUE SCRAPER | Ontel Products Corp. | 1998-05-20 |
| K980075 | CYBERSONIC | American Dentronics, Inc. | 1998-03-04 |
| K973424 | ENFRESH TONGUE BRUSH | Enfresh Products, LLC | 1997-12-09 |
| K973175 | TONGUE KLEAN | Softek Ent. | 1997-10-14 |
| K972644 | BREATH-SO-FRESH TONGUE CLEANER | Intl. Dental Design Specialists, Inc. | 1997-09-11 |
| K972131 | BREATH ACE BREATHFRESHENER | Beyond 21st Century, Inc. | 1997-07-18 |
| K971887 | BREATH TAKER | Hofa, LLC | 1997-06-10 |
| K971025 | AYURVEDIC TONGUE CLEANER | Calello Martinez P.C. | 1997-05-22 |
| K970042 | OOLI-U(TONGUE SCRAPER) | Telefax Intl. | 1997-03-14 |
| K962941 | OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE | Deep Trading Corp. | 1996-10-08 |
| K961574 | TONGUE SCRAPPER | U.S. Dentek Corp. | 1996-06-10 |
| K961660 | TONGUE CLEANER | Jack Conrey | 1996-05-31 |
| K952446 | TONGUE CLEAN | 1-800-Tongues, Inc. | 1995-06-22 |
| K942076 | TONGUE SCRAPER | Maharishi Ayur-Ved | 1994-08-23 |
| K932839 | A MANO TONGUE CLEANSER | A Mano Products, Ltd. | 1993-09-23 |
| K902164 | SYB, OR SAVE YOUR BREATH TONGUE CLEANER | P.J., Inc. | 1990-10-12 |
| K901408 | THE TONGUE BRUSH | Garry Laboratories, Inc. | 1990-05-21 |
| K892388 | THE TONGUE CLEANER | Rajiv R. Shah | 1989-06-16 |
| K870875 | COAT-A-COUNT PCP KIT NUMBER TKPC1 | Diagnostic Products Corp. | 1987-03-19 |
| K851006 | T-SWIPE -TONGUE CLEANER | Kumar Ent. | 1985-05-21 |
| K844292 | MEDI-TECH DILATATION CATHETERS | Medi-Tech, Inc. | 1984-11-23 |
| K844291 | ARK TONGUE CLEANER | Arkay Co. | 1984-11-23 |
| K841077 | ARK TONGUE CLEANER | Arkay Co. | 1984-07-02 |
| K833838 | SILVERAK | Anil S. Gautam | 1984-03-02 |
| K810149 | TONGUE CLEANER | Agp, Inc. | 1981-02-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810131044732 | Adult SuperScraper Rose Gold | Supermouth LLC | 2025-06-30 |
| 00810131044725 | Adult SuperScraper Silver | Supermouth LLC | 2025-06-30 |
| 10304040192488 | Henry Schein | HENRY SCHEIN, INC. | 2025-06-27 |
| 00304040192481 | Henry Schein | HENRY SCHEIN, INC. | 2025-06-27 |
| 00810131041502 | Adult Resuable Tongue Scraper | Supermouth LLC | 2025-05-25 |
| 00810131041526 | Ortho Resuable Tongue Scraper Rose Gold | Supermouth LLC | 2025-05-25 |
| 00810131041519 | Ortho Resuable Tongue Scraper Silver | Supermouth LLC | 2025-05-25 |
| 00817612021008 | Dale Scrape-n-Suction Tongue Cleaner | Dale Medical Products, Inc. | 2024-12-02 |
| 00070942007849 | GUM® | SUNSTAR AMERICAS, INC. | 2024-10-30 |
| D2486300620 | TS1 Tongue Vacuum Cleaner | HAGER WORLDWIDE, INC. | 2024-08-20 |
| D2486300621 | TS1 Tongue Vacuum Cleaner | HAGER WORLDWIDE, INC. | 2024-08-20 |
| 00850036799603 | Adult Tongue Scraper | Supermouth LLC | 2024-06-01 |
| 00810131040529 | Ortho Tongue scraper Silver | Supermouth LLC | 2024-06-01 |
| 00810131040536 | Ortho Tongue scraper Rose Gold | Supermouth LLC | 2024-06-01 |
| 00850036799511 | Chocolate Kids Tongue Scraper Single Scoop | Supermouth LLC | 2024-06-01 |
| 00850036799528 | Strawberry Kids Tongue Scraper Single Scoop | Supermouth LLC | 2024-06-01 |
| 00850036799535 | Vanilla Kids Tongue Scraper Single Scoop | Supermouth LLC | 2024-06-01 |
| 00850036799542 | Chocolate Kids Tongue Scraper Double Scoops | Supermouth LLC | 2024-06-01 |
| 00850036799559 | Strawberry Kids Tongue Scraper Double Scoops | Supermouth LLC | 2024-06-01 |
| 00850036799566 | Vanilla Kids Tongue Scraper Double Scoops | Supermouth LLC | 2024-06-01 |
| 06975983272130 | Momcozy | Shenzhen Lutejiacheng Supply Chain Management Co., Ltd. | 2024-03-27 |
| 08908022377037 | Perfora | CHIPPER CONSUMER PRIVATE LIMITED | 2023-08-04 |
| 00723896023686 | Plastic Tongue Cleaners | PRACTICON, INC. | 2023-06-08 |
| 00723896023679 | Plastic Tongue Cleaners | PRACTICON, INC. | 2023-06-08 |
| 10818207022964 | Vista tongue Cleaners | Vista Dental | 2022-09-01 |
| 00050428272695 | CVS Health | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2020-12-02 |
| 00817612021015 | Dale Strapless Bendable Armboard | DALE MEDICAL PRODUCTS, INC. | 2020-09-14 |
| 00036800442245 | TopCare | Topco Associates, LLC | 2020-06-24 |
| 00311917197371 | Walgreens | WALGREEN CO. | 2020-05-28 |
| 10304040036577 | Henry Schein | HENRY SCHEIN, INC. | 2019-01-25 |