FDA 510(k) Applications for Medical Device:
Bracket, Plastic, Orthodontic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K081143 | BIOMERS PRODUCT, LLC |
2316 PINE RIDGE ROAD | NAPLES | FL | 34109 |
| K110796 | BIOMERS PRODUCTS, LLC |
1275 WEST 6TH AVENUE | VANCOUVER, BC | V6H 1A6 | |
| K182338 | Blue Sky Bio |
888 E Belvedere Rd Suite 212 | Grayslake | IL | 60030 |
| K201940 | Braces on Demand, Inc |
422 South Broadway, Suite 223 | Hicksville | NY | 11801 |
| K082207 | CADENT, INC. |
1700 PENNSYLVANIA AVE NW | WASHINGTON | DC | 20006 |
| K973776 | CDB CORP. |
9201 INDUSTRIAL BLVD. | LELAND | NC | 28451 |
| K052370 | DENTSPLY INTERNATIONAL |
221 WEST PHILADELPHIA ST. | YORK | PA | 17404 |
| K092030 | DENTSPLY INTERNTIONAL |
221 W. PHILADELPHIA ST. STE.60 | YORK | PA | 17405 |
| K251196 | EC Certification Service GmbH |
Sandgasse 39a | Sankt Veit an der Glan | 9300 | |
| K052714 | FDA AGENTS |
17401 COMMERCE PARK BLVD. | TAMPA | FL | 33647 |
| K053055 | GESTENCO INTERNATIONAL AB |
14 FRIDKULLAGATAN | GOTEBORG | SE 400 22 | |
| K150702 | GREAT LAKES ORTHODONTICS, LTD. |
200 COOPER AVE | TONAWANDA | NY | 14150 |
| K981433 | MIDWEST ORTHODONTIC MFG. |
4570 PROGRESS DR. | COLUMBUS | IN | 47201 |
| K150830 | ORACREW |
210 E Flamingo Rd. #217 | Las Vegas | NV | 89169 |
| K101676 | ORMCO CORP. |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K052477 | ORMCO CORP. |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K121524 | ORMCO CORP. |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K123118 | ORMCO CORP. |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K123416 | ORMCO CORP. |
1717 WEST COLLINS AVENUE | ORANGE | CA | 92867 |
| K955333 | ORMCO CORP. |
1332 SOUTH LONE HILL AVE. | GLENDORA | CA | 91740 |
| K160720 | ORTHO ORGANIZERS, INC. |
1822 ASTON AVENUE | CARLSBAD | CA | 92008 |
| K140807 | ORTHO SPECIALTIES |
207 PHEASANT MEADOW CT. | GURNEE | IL | 60031 |
| K051953 | STICK TECH LTD. |
80 PARKWAY WEST | MOUNT VERNON | NY | 10552 |
| K061042 | SYBRON DENTAL SPECIALTIES |
100 BAYVIEW CIRCLE | NEWPORT BEACH | CA | 92660-8915 |
| K032408 | SYBRON DENTAL SPECIALTIES, INC. |
1717 W. COLLINS AVE. | ORANGE | CA | 92867 |
| K180718 | TOMY, Inc. |
Tenko Bldg. 3-16-7 | Midori-cho, Fuchu City | 183-0006 | |
| K050730 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K071055 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K032625 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
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