The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer 3.1mm Dental Implant;2.9mm Angled Abutment;straight Hex, 2.9mm Contour Abutement.
| Device ID | K142082 |
| 510k Number | K142082 |
| Device Name: | ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Contact | Christina Boydson |
| Correspondent | Christina Boydson ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad, CA 92008 -7308 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-31 |
| Decision Date | 2014-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024343955 | K142082 | 000 |
| 00889024343924 | K142082 | 000 |
| 00889024343917 | K142082 | 000 |
| 00889024343900 | K142082 | 000 |
| 00889024343894 | K142082 | 000 |
| 00889024343887 | K142082 | 000 |
| 00889024343870 | K142082 | 000 |
| 00889024343627 | K142082 | 000 |
| 00889024343610 | K142082 | 000 |
| 00889024343603 | K142082 | 000 |
| 00889024343597 | K142082 | 000 |
| 00889024343580 | K142082 | 000 |
| 00889024343450 | K142082 | 000 |
| 00889024343443 | K142082 | 000 |
| 00889024343436 | K142082 | 000 |
| 00889024343429 | K142082 | 000 |
| 00889024343412 | K142082 | 000 |
| 00889024343078 | K142082 | 000 |
| 00889024343085 | K142082 | 000 |
| 00889024343948 | K142082 | 000 |
| 00889024343931 | K142082 | 000 |
| 00889024343337 | K142082 | 000 |
| 00889024343320 | K142082 | 000 |
| 00889024343313 | K142082 | 000 |
| 00889024343306 | K142082 | 000 |
| 00889024343184 | K142082 | 000 |
| 00889024343177 | K142082 | 000 |
| 00889024343160 | K142082 | 000 |
| 00889024343153 | K142082 | 000 |
| 00889024343146 | K142082 | 000 |
| 00889024343139 | K142082 | 000 |
| 00889024343122 | K142082 | 000 |
| 00889024343115 | K142082 | 000 |
| 00889024343108 | K142082 | 000 |
| 00889024343092 | K142082 | 000 |
| 00889024343405 | K142082 | 000 |