510(k) K973175
- Device
- Tongue Klean
- Applicant
- SOFTEK ENT.
- 510(k) number
- K973175
- Product code
- LCN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-10-14
- Date received
- 1997-08-25
- 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
- PROMILA GUPTA
- Address
- 5245 S. Hanover Way Englewood CO US 80111 80111
FDA Registration Numbers#
- 3003062321
- 3003761382
- 3006750878
- 3004753334
- 3008729549
- 3007165189
- 3008103948
- 3033858988
- 3019804885
- 3005980667
- 3012133441
- 3008346537
- 1051614
- 3012742764
- 3013120141
- 3010119775
- 3007113238
- 3016447301
- 3005816808
- 3024337922
- 3009926836
- 3043648115
- 3013519273
- 3005904818
- 3002343253
- 3013645257
- 3008262609
- 3043476844
- 3024512680
- 2531570
- 3005558160
- 3005277354
- 3030507585
- 3007663061
- 3039396072
- 2246990
- 3008808087
- 3006130829
- 3020703715
- 3004069780
- 3009171220
- 3022296393
- 3006540944
- 3006437215
- 3005951403
- 3006639573
- 3027257639
- 3009220523
- 3003361112
- 3011964664
- 3011456684
- 2938386
- 3012117640
- 3015553940
- 3020393302
- 3027234828
- 3013205789
- 3006795917
- 1000308786
- 3010288346
- 3018258389
- 3011205500
- 3015140246
- 3019912897
- 3016818428
- 3006608997
- 3004605493
- 3011484062
- 3015128224
- 8040278
- 3015432501
- 9681207
- 3008254143
- 3042278984
- 3003965504
- 3004425647
- 3017352116
- 3013946322
- 1044031
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 |
| K973424 | ENFRESH TONGUE BRUSH | Enfresh Products, LLC | 1997-12-09 |
| 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 |