The following data is part of a premarket notification filed by American Dental Implant Corporation with the FDA for American Dental Implant.
| Device ID | K042462 |
| 510k Number | K042462 |
| Device Name: | AMERICAN DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | AMERICAN DENTAL IMPLANT CORPORATION 2415 WILMINGTON RD. New Castle, PA 16105 |
| Contact | Steven B Lombardi |
| Correspondent | Steven B Lombardi AMERICAN DENTAL IMPLANT CORPORATION 2415 WILMINGTON RD. New Castle, PA 16105 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-10 |
| Decision Date | 2004-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D896GT47115HA0 | K042462 | 000 |
| D8964716RBM0 | K042462 | 000 |
| D8964716HA0 | K042462 | 000 |
| D8964713RBM0 | K042462 | 000 |
| D8964713HA0 | K042462 | 000 |
| D89647115RBM0 | K042462 | 000 |
| D89647115HA0 | K042462 | 000 |
| D8964710RBM0 | K042462 | 000 |
| D8964710HA0 | K042462 | 000 |
| D8964708RBM0 | K042462 | 000 |
| D8964708HA0 | K042462 | 000 |
| D8963716RBM0 | K042462 | 000 |
| D896GT3708HA0 | K042462 | 000 |
| D896GT3708RBM0 | K042462 | 000 |
| D896GT3710HA0 | K042462 | 000 |
| D896GT4710RBM0 | K042462 | 000 |
| D896GT4710HA0 | K042462 | 000 |
| D896GT4708RBM0 | K042462 | 000 |
| D896GT4708HA0 | K042462 | 000 |
| D896GT3716RBM0 | K042462 | 000 |
| D896GT3716HA0 | K042462 | 000 |
| D896GT3713RBM0 | K042462 | 000 |
| D896GT3713HA0 | K042462 | 000 |
| D896GT37115RBM0 | K042462 | 000 |
| D896GT37115HA0 | K042462 | 000 |
| D896GT3710RBM0 | K042462 | 000 |
| D8963716HA0 | K042462 | 000 |
| D8963713RBM0 | K042462 | 000 |
| D89633SD10HA0 | K042462 | 000 |
| D89633SD08RBM0 | K042462 | 000 |
| D89633SD08HA0 | K042462 | 000 |
| D8962416RBM0 | K042462 | 000 |
| D8962416HA0 | K042462 | 000 |
| D8962413RBM0 | K042462 | 000 |
| D8962413HA0 | K042462 | 000 |
| D89624115RBM0 | K042462 | 000 |
| D89624115HA0 | K042462 | 000 |
| D8962410RBM0 | K042462 | 000 |
| D8962410HA0 | K042462 | 000 |
| D89633SD10RBM0 | K042462 | 000 |
| D89633SD115HA0 | K042462 | 000 |
| D89633SD115RBM0 | K042462 | 000 |
| D8963713HA0 | K042462 | 000 |
| D89637115RBM0 | K042462 | 000 |
| D89637115HA0 | K042462 | 000 |
| D8963710RBM0 | K042462 | 000 |
| D8963710HA0 | K042462 | 000 |
| D8963708RBM0 | K042462 | 000 |
| D8963708HA0 | K042462 | 000 |
| D89633SD16RBM0 | K042462 | 000 |
| D89633SD16HA0 | K042462 | 000 |
| D89633SD13RBM0 | K042462 | 000 |
| D89633SD13HA0 | K042462 | 000 |
| D892T3210RBM0 | K042462 | 000 |
| D896T6016RBM0 | K042462 | 000 |
| D896T47115HA0 | K042462 | 000 |
| D896T4710RBM0 | K042462 | 000 |
| D896T4710HA0 | K042462 | 000 |
| D896T4708RBM0 | K042462 | 000 |
| D896T4708HA0 | K042462 | 000 |
| D896T3716RBM0 | K042462 | 000 |
| D896T3716HA0 | K042462 | 000 |
| D896T3713RBM0 | K042462 | 000 |
| D896T3713HA0 | K042462 | 000 |
| D896T37115RBM0 | K042462 | 000 |
| D896T37115HA0 | K042462 | 000 |
| D896T47115RBM0 | K042462 | 000 |
| D896T4713HA0 | K042462 | 000 |
| D896T4713RBM0 | K042462 | 000 |
| D896T6016HA0 | K042462 | 000 |
| D896T6013RBM0 | K042462 | 000 |
| D896T6013HA0 | K042462 | 000 |
| D896T60115RBM0 | K042462 | 000 |
| D896T60115HA0 | K042462 | 000 |
| D896T6010RBM0 | K042462 | 000 |
| D896T6010HA0 | K042462 | 000 |
| D896T6008RBM0 | K042462 | 000 |
| D896T6008HA0 | K042462 | 000 |
| D896T4716RBM0 | K042462 | 000 |
| D896T4716HA0 | K042462 | 000 |
| D896T3710RBM0 | K042462 | 000 |
| D896T3710HA0 | K042462 | 000 |
| D896GT6013HA0 | K042462 | 000 |
| D896GT60115RBM0 | K042462 | 000 |
| D896GT60115HA0 | K042462 | 000 |
| D896GT6010RBM0 | K042462 | 000 |
| D896GT6010HA0 | K042462 | 000 |
| D896GT6008RBM0 | K042462 | 000 |
| D896GT6008HA0 | K042462 | 000 |
| D896GT4716RBM0 | K042462 | 000 |
| D896GT4716HA0 | K042462 | 000 |
| D896GT4713RBM0 | K042462 | 000 |
| D896GT4713HA0 | K042462 | 000 |
| D896GT6013RBM0 | K042462 | 000 |
| D896GT6016HA0 | K042462 | 000 |
| D896GT6016RBM0 | K042462 | 000 |
| D896T3708RBM0 | K042462 | 000 |
| D896T3708HA0 | K042462 | 000 |
| D896T3216RBM0 | K042462 | 000 |
| D896T3216HA0 | K042462 | 000 |
| D896T3213RBM0 | K042462 | 000 |
| D896T3213HA0 | K042462 | 000 |
| D896T32115RBM0 | K042462 | 000 |
| D896T32115HA0 | K042462 | 000 |
| D896T3210HA0 | K042462 | 000 |
| D896T3208RBM0 | K042462 | 000 |
| D896T3208HA0 | K042462 | 000 |
| D896GT47115RBM0 | K042462 | 000 |