FDA 510(k) Applications for Medical Device:
Cord, Retraction
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K093721 | 3M ESPE AG DENTAL PRODUCTS |
ESPE PLATZ | SEEFELD, BAVARIA | D-82229 | |
| K211419 | Belport Company, Inc., Gingi-Pak |
4825 Calle Alto | Camarillo | CA | 93012 |
| K211420 | Belport Company, Inc., Gingi-Pak |
4825 Calle Alto | Camarillo | CA | 93012 |
| K053329 | BIOTECH ONE, INC. |
92 COSTA BRAVA | LAGUNA NIGUEL | CA | 92677 |
| K200764 | Centrix Incorporated |
770 River Road | Shelton | CT | 06484 |
| K091380 | CENTRIX, INC. |
770 RIVER RD. | SHELTON | CT | 06484-5458 |
| K092384 | CENTRIX, INC. |
770 RIVER RD. | SHELTON | CT | 06484-5458 |
| K111348 | CENTRIX, INC. |
770 RIVER RD. | SHELTON | CT | 06484-5458 |
| K041023 | COLTENE/WHALEDENT GMBH & CO. KG |
CARE OF HENRY J. VOGELSTEIN | NEW YORK | NY | 10128 |
| K130580 | DMG USA, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K171577 | EASTDENT Co., Ltd |
601-1 Sogong B/D, 64 Gugal-ro, Giheung-gu | Yongin-si | 16972 | |
| K193389 | Inter-Med / Vista Dental Products |
2200 South St. Ste. A | Racine | WI | 53404 |
| K190220 | Inter-Med / Vista Dental Products |
2200 South St. Ste. A | Racine | WI | 53404 |
| K162164 | KERR CORPORATION |
1717 W. COLLINS AVE | ORANGE | CA | 92867 |
| K162536 | KERR CORPORATION |
1717 W. COLLINS AVE | ORANGE | CA | 92867 |
| K102133 | KERR CORPORATION |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K162948 | KERR CORPORATION |
1717 W. COLLINS AVE. | ORANGE | CA | 92867 |
| K101756 | KERR CORPORATION |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K131799 | MICROCOPY, DIV. OF NEO-FLO INC. |
3120 MOON STATION RD. NW | KENNESAW | GA | 30144-9017 |
| K162662 | PAC-DENT INTERNATIONAL, INC. |
670 ENDEAVOR CIRCLE | BREA | CA | 92821 |
| K113839 | PARKELL, INC. |
300 EXECUTIVE DR. | EDGEWOOD | NY | 11717 |
| K132526 | PREMIER DENTAL PRODUCTS CO. |
1710 ROMANO DR. | PLYMOUTH MEETING | PA | 19462 |
| K083695 | PREMIER DENTAL PRODUCTS CO. |
1710 ROMANO DR. | PLYMOUTH MEETING | PA | 19462 |
| K050180 | PRODUITS DENTAIRES PIERRE ROLLAND |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K111978 | PRODUITS DENTAIRES PIERRE ROLLAND |
124 GAITHER DRIVE | MT. LAUREL | NJ | 08054 |
| K150423 | PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP) |
17 AVENUE GUSTAVE EIFFEL | MERIGNAC | 33708 | |
| K082116 | SATELEC |
124 GAITHER DRIVE | MT. LAUREL | NJ | 08054 |
| K093711 | SEPTODONT |
1050 CONNECTICUT AVE., NW | WASHINGTON | DC | 20036 |
| K152064 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K981596 | ULTRADENT PRODUCTS, INC. |
505 W. 10200 SO. | SOUTH JORDAN | UT | 84095-3935 |
| K010070 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K123215 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K213149 | Voco GmbH |
Anton-Flettner-Str. 1-3 | Cuxhaven | 27472 |
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