FDA.reportPublic FDA data

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#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LCN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992270MIRACLEBREATH TONGUE CLEANERStellar Labs, Inc.1999-09-23
K990344ORALGIENE TONGUE CLEANEROralgiene USA, Inc.1999-05-04
K983683UNIK TONGUE CLEANERUnik Products, Inc.1999-01-14
K983087BREATHTIQUE TONGUE SCRAPERCustom Medical Arts, Inc.1998-11-18
K981808BREATHAID TONGUE SCRAPERBreathaid, LLC1998-08-11
K980842COPPER TONGUE SCRAPEROntel Products Corp.1998-05-20
K980075CYBERSONICAmerican Dentronics, Inc.1998-03-04
K973424ENFRESH TONGUE BRUSHEnfresh Products, LLC1997-12-09
K972644BREATH-SO-FRESH TONGUE CLEANERIntl. Dental Design Specialists, Inc.1997-09-11
K972131BREATH ACE BREATHFRESHENERBeyond 21st Century, Inc.1997-07-18
K971887BREATH TAKERHofa, LLC1997-06-10
K971025AYURVEDIC TONGUE CLEANERCalello Martinez P.C.1997-05-22
K970042OOLI-U(TONGUE SCRAPER)Telefax Intl.1997-03-14
K962941OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZEDeep Trading Corp.1996-10-08
K961574TONGUE SCRAPPERU.S. Dentek Corp.1996-06-10