Product Code: LCN
FDA class 1
21 CFR 872.6855
Scraper, Tongue
Dental
A tongue scraper is a simple dental hygiene device used to mechanically remove biofilm, debris, and bacteria from the surface of the tongue to reduce oral malodor and improve oral hygiene. It is classified as FDA Class 1, reflecting very low risk, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is LCN, regulated under 21 CFR 872.6855, in the Dental specialty. No premarket notification is required.
510(k)s
31
FEI Numbers
154
Registration Numbers
155
Unique Applicants
30
Years Active
20
Basic Information
- Product Code
- LCN
- Device Class
- FDA class 1
- Regulation Number
- 872.6855
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
✓
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 31 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K992270 | MIRACLEBREATH TONGUE CLEANER | Sep 23, 1999 | Substantially Equivalent | STELLAR LABS, INC. |
| K990344 | ORALGIENE TONGUE CLEANER | May 04, 1999 | Substantially Equivalent | ORALGIENE USA, INC. |
| K983683 | UNIK TONGUE CLEANER | Jan 14, 1999 | Substantially Equivalent | UNIK PRODUCTS, INC. |
| K983087 | BREATHTIQUE TONGUE SCRAPER | Nov 18, 1998 | Substantially Equivalent | CUSTOM MEDICAL ARTS, INC. |
| K981808 | BREATHAID TONGUE SCRAPER | Aug 11, 1998 | Substantially Equivalent | BREATHAID, LLC. |
| K980842 | COPPER TONGUE SCRAPER | May 20, 1998 | Substantially Equivalent | ONTEL PRODUCTS CORP. |
| K980075 | CYBERSONIC | Mar 04, 1998 | Substantially Equivalent | AMERICAN DENTRONICS, INC. |
| K973424 | ENFRESH TONGUE BRUSH | Dec 09, 1997 | Substantially Equivalent | ENFRESH PRODUCTS LLC. |
| K973175 | TONGUE KLEAN | Oct 14, 1997 | Substantially Equivalent | SOFTEK ENT. |
| K972644 | BREATH-SO-FRESH TONGUE CLEANER | Sep 11, 1997 | Substantially Equivalent | INTL. DENTAL DESIGN SPECIALISTS, INC. |
| K972131 | BREATH ACE BREATHFRESHENER | Jul 18, 1997 | Substantially Equivalent | BEYOND 21ST CENTURY, INC. |
| K971887 | BREATH TAKER | Jun 10, 1997 | Substantially Equivalent | HOFA LLC. |
| K971025 | AYURVEDIC TONGUE CLEANER | May 22, 1997 | Substantially Equivalent | CALELLO MARTINEZ P.C. |
| K970042 | OOLI-U(TONGUE SCRAPER) | Mar 14, 1997 | Substantially Equivalent | TELEFAX INTL. |
| K962941 | OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE | Oct 08, 1996 | Substantially Equivalent | DEEP TRADING CORP. |
| K961574 | TONGUE SCRAPPER | Jun 10, 1996 | Substantially Equivalent | U.S. DENTEK CORP. |
| K961660 | TONGUE CLEANER | May 31, 1996 | Substantially Equivalent | JACK CONREY |
| K952446 | TONGUE CLEAN | Jun 22, 1995 | Substantially Equivalent | 1-800-TONGUES, INC. |
| K942076 | TONGUE SCRAPER | Aug 23, 1994 | Substantially Equivalent | MAHARISHI AYUR-VED |
| K932839 | A MANO TONGUE CLEANSER | Sep 23, 1993 | Substantially Equivalent | A MANO PRODUCTS, LTD. |
| K902164 | SYB, OR SAVE YOUR BREATH TONGUE CLEANER | Oct 12, 1990 | Substantially Equivalent | P.J., INC. |
| K901408 | THE TONGUE BRUSH | May 21, 1990 | Substantially Equivalent | GARRY LABORATORIES, INC. |
| K892388 | THE TONGUE CLEANER | Jun 16, 1989 | Substantially Equivalent | RAJIV R. SHAH |
| K870875 | COAT-A-COUNT PCP KIT NUMBER TKPC1 | Mar 19, 1987 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K851006 | T-SWIPE -TONGUE CLEANER | May 21, 1985 | Substantially Equivalent | KUMAR ENT. |
| K844292 | MEDI-TECH DILATATION CATHETERS | Nov 23, 1984 | Substantially Equivalent | MEDI-TECH, INC. |
| K844291 | ARK TONGUE CLEANER | Nov 23, 1984 | Substantially Equivalent | ARKAY CO. |
| K841077 | ARK TONGUE CLEANER | Jul 02, 1984 | Substantially Equivalent | ARKAY CO. |
| K833838 | SILVERAK | Mar 02, 1984 | Substantially Equivalent | ANIL S. GAUTAM |
| K810149 | TONGUE CLEANER | Feb 05, 1981 | Substantially Equivalent | AGP, INC. |
| K790895 | TONGUE SCRAPER | Sep 04, 1979 | Substantially Equivalent | PETER G. FINAMORE, SR. |
FEI Numbers
This FDA classification entry is associated with 154 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 155 registration numbers. Click on an entry to view related FDA registrations.