FDA 510(k) Applications for Medical Device:
Cleanser, Root Canal
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K030884 |
ACADENTAL |
5830 WOODSON ST.
| MISSION |
KS |
66202 |
K130180 |
CERKAMED WOJCIECH PAWLOWSKI |
KWIATKOWSKIEGO 1 STREET
| STALOWA WOLA, PODKARPACIE |
|
37-450 |
K032361 |
DENTSPLY INTL. |
570 WEST COLLEGE AVENUE
| YORK |
PA |
17405-0872 |
K053167 |
DENTSPLY INTL., INC. |
SUSQUEHANNA COMMERCE CENTER
| YORK |
PA |
17404 |
K103244 |
DENTSPLY INTL., INC. |
SUSQUEHANNA COMMERCE CENTER
| YORK |
PA |
17404 |
K201785 |
EPIEN Medical, Inc. |
4225 White Bear Parkway Suite 600
| St. Paul |
MN |
55110 |
K123538 |
EPIEN MEDICAL, INC. |
700 THIRTEENTH ST. NW STUITE 200
| WASHINGTON |
DC |
20005 |
K140846 |
ESSENTIAL DENTAL SYSTEMS, INC. |
89 LEUNING STREET
| SOUTH HACKENSACK |
NJ |
07606 |
K072555 |
ESSENTIAL DENTAL SYSTEMS, INC. |
89 LEUNING ST.
| SOUTH HACKENSACK |
NJ |
07606 |
K070401 |
ESSENTIAL DENTAL SYSTEMS, INC. |
55 NORTHERN BLVD., SUITE 200
| GREAT NECK |
NY |
11021 |
K150020 |
ESSENTIAL DENTAL SYSTESM, INC. |
89 LEUNING STREET, SUITE 8
| SOUTH HACKENSACK |
NJ |
07606 |
K162311 |
INSTITUT STRAUMANN AG |
PETER MERIAN WEG 12
| BASEL |
|
CH-4002 |
K211813 |
Inter-Med / Vista Dental |
2200 South Street
| Racine |
WI |
53404 |
K112250 |
INTER-MED, INC. |
2200 NORTHWESTERN AVE.
| RACINE |
WI |
53404 |
K082470 |
INTER-MED, INC. |
2200 NORTHWESTERN AVE.
| RACINE |
WI |
53404 |
K193357 |
Inter-Med/ Vista Dental Products |
2220 South Street Suite A
| Racine |
WI |
53404 |
K193409 |
Inter-Med/Vista Dental Products |
2200 South St. Ste. A
| Racine |
WI |
53404 |
K992484 |
JORDCO, INC. |
595 N.W. 167TH AVE.
| BEAVERTON |
OR |
97006 |
K141352 |
OCULUS INNOVATIVE SCIENCES |
1129 N MCDOWELL BLVD
| PETALUMA |
CA |
94954 |
K160577 |
PAC-DENT INTERNATIONAL, INC. |
670 ENDEAVOR CIRCLE
| BREA |
CA |
92821 |
K153528 |
PAC-DENT INTERNATIONAL, INC. |
670 ENDEAVOR CIRCLE
| Brea |
CA |
92821 |
K151852 |
PAC-DENT INTERNATIONAL, INC. |
670 ENDEAVOR CIRCLE
| BREA |
CA |
92821 |
K200330 |
Pac-Dent, Inc |
670 Endeavor Circle
| Brea |
CA |
92821 |
K962743 |
PULPDENT CORP. |
80 OAKLAND ST.
| WATERTOWN |
MA |
02472 |
K061689 |
PURICORE, INC. |
320 KING OF PRUSSIA ROAD
| RADNOR |
PA |
19087 |
K063812 |
STRAUMANN USA |
60 MINUTETEMAN ROAD
| ANDOVER |
MA |
01810 |
K003422 |
SUPER GLIDE, INC. |
227 COLCHESTER AVE.
| BURLINGTON |
VT |
05401 |
K992919 |
SUPER GLIDE, INC. |
227 COLCHESTER AVE.
| BURLINGTON |
VT |
05401 |
K024198 |
SYBRON DENTAL SPECIALTIES, INC. |
1717 WEST COLLINS AVE.
| ORANGE |
CA |
92867 |
K173163 |
Ultradent Products, Inc. |
505 W Ultradent Drive (10200 South)
| South Jordan |
UT |
84095 |
K063703 |
ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH
| SOUTH JORDAN |
UT |
84095 |
K060335 |
ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH
| SOUTH JORDAN |
UT |
84095 |
K032627 |
ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH
| SOUTH JORDAN |
UT |
84095 |
|
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