The following data is part of a premarket notification filed by Intra-lock International with the FDA for Endossous Implants.
| Device ID | K021322 |
| 510k Number | K021322 |
| Device Name: | ENDOSSOUS IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INTRA-LOCK INTERNATIONAL 1200 N. FEDERAL HWY SUITE#200 Boca Raton, FL 33432 |
| Contact | Jeffery Sakoff |
| Correspondent | Jeffery Sakoff INTRA-LOCK INTERNATIONAL 1200 N. FEDERAL HWY SUITE#200 Boca Raton, FL 33432 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-25 |
| Decision Date | 2002-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D742FTNPC0 | K021322 | 000 |
| D742IH15W0 | K021322 | 000 |
| D742IH15W20 | K021322 | 000 |
| D742IH15W30 | K021322 | 000 |
| D742IH250 | K021322 | 000 |
| D742IH2520 | K021322 | 000 |
| D742IH2530 | K021322 | 000 |
| D742IH25W0 | K021322 | 000 |
| D742IH25W20 | K021322 | 000 |
| D742IH25W30 | K021322 | 000 |
| D742IHHA30 | K021322 | 000 |
| D742FANSCBA0 | K021322 | 000 |
| D742FANSTC0 | K021322 | 000 |
| D742FASCBA0 | K021322 | 000 |
| D742IH1530 | K021322 | 000 |
| D742IH1520 | K021322 | 000 |
| D742FTNTC0 | K021322 | 000 |
| D742FTPC0 | K021322 | 000 |
| D742FTTC0 | K021322 | 000 |
| D742IHA3EP0 | K021322 | 000 |
| D742IHA3WEP0 | K021322 | 000 |
| D742INICA0 | K021322 | 000 |
| D742IHHA3W0 | K021322 | 000 |
| D742IHHA4W0 | K021322 | 000 |
| D742IHHA5W0 | K021322 | 000 |
| D742IH40100 | K021322 | 000 |
| D742IH40110 | K021322 | 000 |
| D742IH40130 | K021322 | 000 |
| D742IH150 | K021322 | 000 |
| D742FASTC0 | K021322 | 000 |
| D742FANTIBASE0 | K021322 | 000 |
| D742FATIBASE0 | K021322 | 000 |
| D742IHA30 | K021322 | 000 |
| D742IHA3W0 | K021322 | 000 |
| D742IH34080 | K021322 | 000 |
| D742IH34100 | K021322 | 000 |
| D742IH34110 | K021322 | 000 |
| D742IH34130 | K021322 | 000 |
| D742IH34150 | K021322 | 000 |
| D742IH47060 | K021322 | 000 |
| D742IH47080 | K021322 | 000 |
| D742IH60060 | K021322 | 000 |
| D742IH60080 | K021322 | 000 |
| D742IH60100 | K021322 | 000 |
| D742IH60110 | K021322 | 000 |
| D742IBA20 | K021322 | 000 |
| D742IHTICOWS0 | K021322 | 000 |
| D742IHCAA170 | K021322 | 000 |
| D742IHCAA17W0 | K021322 | 000 |
| D742IHHA40 | K021322 | 000 |
| D742IHHA50 | K021322 | 000 |
| D742IHSA10 | K021322 | 000 |
| D742IHSA20 | K021322 | 000 |
| D742IHSA30 | K021322 | 000 |
| D742CCA170 | K021322 | 000 |
| D742CTA170 | K021322 | 000 |
| D742IGCSW0 | K021322 | 000 |
| D742IHTICO0 | K021322 | 000 |
| D742IHTICOS0 | K021322 | 000 |
| D742IHTICOW0 | K021322 | 000 |
| D742HSAW20 | K021322 | 000 |