FDA 510(k) Applications for Medical Device: Mouthguard, Over-The-Counter

FDA 510(k) Applications for Medical Device:
Mouthguard, Over-The-Counter

FDA 510(k) Number	Applicant	Address	City / Country	State / Province	Postal Code
K121272	AKERVALL TECHNOLOGIES INC	5520 STONE VALLEY DRIVE	ANN ARBOR	MI	48105
K073446	ARCHTEK, INC.	1705 SOUTH CAPITOL OF TEXAS HW	AUSTIN	TX	78746
K150492	Bite Tech Inc.	20 Glover Avenue	Norwalk	CT	06850
K181005	Boyd Research, Inc.	506 Pacific Ave	Solana Beach	CA	92075
K211158	Boyd Research, Inc.	5820 Bali Way S	St. Pete Beach	FL	33706
K072147	DEN TEK ORAL CARE, INC.	555 THIRTEENTH STREET, NW	WASHINGTON	DC	20004
K111310	DENTAL ARTE, INC.	7046 OWL'S NEST TERR	BRADERDON	FL	34203
K183315	Dental Choice Holdings, LLC	10100 Linn Station Road	Louisville	KY	40223
K083400	DENTEK ORAL CARE, INC.	555 THIRTEENTH STREET, NW	WASHINGTON	DC	20004
K091660	DENTEK ORAL CARE, INC.	555 THIRTEENTH STREET, NW	WASHINGTON	DC	20004
K081669	DENTEK ORAL CARE, INC.	555 THIRTEENTH STREET, NW	WASHINGTON	DC	20004
K123849	DENTEK ORAL CARE, INC.	307 EXCELLENCE WAY	MARYVILLE	TN	37801
K151149	DENTEK ORAL CARE, INC.	397 EXCELLENCE WAY	MARYVILLE	TN	37801
K232238	Dimedikorea	Rm.201, 1, Mandeok 3-ro, 16beon-gil, Buk-gu	Busan		46570
K250456	DOC Brands, Inc.	407 E. Lancaster Avenue	Wayne	PA	19087
K222424	DOC Brands, Inc.	407 E. Lancaster Avenue	Wayne	PA	19087
K221369	FBCC Inc	6711 S Sepulveda Blvd, Unit 602	Los Angeles	CA	90045
K133037	GRIND GUARD TECHNOLOGIES, LLC	342 E. MAIN STREET	LEOLA	PA	17540
K132469	INTERNATIONAL PROFIT BUILDERS, INC.	7045 PALM AVE	HIGHLAND	CA	92346
K181099	Koncept Innovators, LLC.	1619 Executive Ave	Myrtle Beach	SC	29577
K191033	McKeon Products	25460 Guenther	Warren	MI	48091
K180933	Medtech Products Inc.	660 White Plains Rd	Tarrytown	NY	10591
K202974	Medtech Products, Inc.	660 White Plains Rd.	Tarrytown	NY	10591
K113326	ORALABS, INC.	18685 EAST PLAZA DRIVE	PARKER	CO	80134
K082301	PLACONTROL INC.	555 THIRTEENTH STREET NW	WASHINGTON	DC	20004
K100545	POWER PRODUCTS, INC.-SPLINTEK	9755 RIDGE DRIVE	LENEXA	KS	66219
K073220	PRESTIGE BRANDS, INC.	90 N BROADWAY	IRVINGTON	NY	10533
K091792	RANIR CORPORATION	555 THIRTEENTH STREET, NW	WASHINGTON	DC	20004
K094020	RANIR LLC	555 THIRTEENTH STREET, NW	WASHINGTON	DC	20004
K091175	RANIR LLC	555 THIRTEENTH STREET, NW	WASHINGTON	DC	20004
K133423	RANIR LLC	4701 EAST PARIS AVE. S.E.	GRAND RAPIDS	MI	49512
K120103	RANIR LLC	555 THIRTEENTH STREET, NW	WASHINGTON	DC	20004
K063229	RANIR LLC	900 FIFTH THIRD CENTER	GRAND RAPIDS	MI	49503
K112879	RANIR LLC	555 THIRTEENTH STREET, NW	WASHINGTON	DC	20004
K231865	Reazeal Corp	1226 North King St. #485	Wilmington	DE	19801
K172452	Sleep Specialties, LLC	2565 South Las Vegas Blvd.,Suite #184	Las Vegas	NV	89109
K212706	Splintek, Inc.	15555 West 108th Street	Lenexa	KS	66219
K172223	Splintek, Inc.	15555 West 108th Street	Lenexa	KS	66219
K193577	Splintek, Inc.	15555 West 108th Street	Lenexa	KS	66219
K072968	TOTALGARD CORPORATION	70 WEST FOSTER STREET	MELROSE	MA	02176
K240810	Xiamen Yizhou Imp. & Exp. Co., Ltd.	2F, 1#, Huli Industrial Park, Meixi Road, Tong An District	Xiamen		361100