510(k) K973424
- Device
- ENFRESH TONGUE BRUSH
- Applicant
- ENFRESH PRODUCTS LLC.
- 510(k) number
- K973424
- Product code
- LCN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-09
- Date received
- 1997-09-10
- Regulation
- 872.6855
- Classification name
- Scraper, Tongue
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HOWARD M HOLSTEIN, ESG
- Address
- 555 13th St., NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3015337442
- 3010164069
- 3021636076
- 3005558160
- 3006113202
- 3014468707
- 3011964664
- 3007663061
- 3009926836
- 3011484062
- 3013519273
- 3027234828
- 3018258389
- 3008770695
- 3014707731
- 3044779578
- 3033858988
- 3042278984
- 3043047788
- 3022296393
- 2087561
- 3007113238
- 3005904818
- 3018418236
- 3007165189
- 3003062321
- 3011409414
- 3033918991
- 2133714
- 3015128224
- 3013972866
- 3009171220
- 3017352116
- 3030507585
- 3008103948
- 3027283275
- 3005816808
- 1000308786
- 3010351588
- 3008254143
- 9710609
- 3010486573
- 3008808087
- 3009488700
- 3010288346
- 3016447301
- 3004102039
- 3012590871
- 3015505238
- 3033815781
- 3004425647
- 3011205500
- 3005980667
- 3010583458
- 1413787
- 3030229213
- 3013946322
- 3024337922
- 3009893622
- 3020703715
- 3009543140
- 3002911411
- 3006639573
- 3006795917
- 3006608997
- 3031191035
- 3003761382
- 9681207
- 3012133441
- 3000099306
- 3008346537
- 3013503739
- 3012742764
- 8040278
- 3008650974
- 3017954358
- 2531570
- 3006789197
- 2183650
Source Documents#
Other 510(k) Records For Product Code LCN #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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