The following data is part of a premarket notification filed by Oraltronics Dental Implant Technology Gmbh with the FDA for Bioresorb Macro Pore.
| Device ID | K050260 |
| 510k Number | K050260 |
| Device Name: | BIORESORB MACRO PORE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH 3234 64TH ST. Lubbock, TX 79413 |
| Contact | Chad Bartee |
| Correspondent | Chad Bartee ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH 3234 64TH ST. Lubbock, TX 79413 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-03 |
| Decision Date | 2005-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260310344157 | K050260 | 000 |
| 04260310344010 | K050260 | 000 |
| 04260310344027 | K050260 | 000 |
| 04260310344034 | K050260 | 000 |
| 04260310344041 | K050260 | 000 |
| 04260310344058 | K050260 | 000 |
| 04260310344065 | K050260 | 000 |
| 04260310344072 | K050260 | 000 |
| 04260310344089 | K050260 | 000 |
| 04260310344096 | K050260 | 000 |
| 04260310344102 | K050260 | 000 |
| 04260310344119 | K050260 | 000 |
| 04260310344126 | K050260 | 000 |
| 04260310344133 | K050260 | 000 |
| 04260310344140 | K050260 | 000 |
| 04260310344003 | K050260 | 000 |