The following data is part of a premarket notification filed by Forestadent Bernhard Forster Gmbh with the FDA for Ortho Easy Pin.
| Device ID | K110275 |
| 510k Number | K110275 |
| Device Name: | ORTHO EASY PIN |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | FORESTADENT BERNHARD FORSTER GMBH 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Tanya O'brien |
| Correspondent | Tanya O'brien FORESTADENT BERNHARD FORSTER GMBH 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-31 |
| Decision Date | 2011-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EFOR1201A23081 | K110275 | 000 |
| EFOR1101A23101 | K110275 | 000 |
| EFOR1101A23081 | K110275 | 000 |
| EFOR1101A23061 | K110275 | 000 |