The following data is part of a premarket notification filed by Sterngold Dental, Llc with the FDA for Stern Ac 3.3x10mm, Stern Ac 3.3x11.5mm, Stern Ac 3.3x13mm, Stern Ac 4.0x8.5mm, Stern Ac 4.0x10mm.
| Device ID | K142667 |
| 510k Number | K142667 |
| Device Name: | Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Sterngold Dental, LLC 23 Frank Mossbery Dr Attleboro, MA 02703 |
| Contact | Maria Rao |
| Correspondent | Maria Rao Sterngold Dental, LLC 23 Frank Mossbery Dr Attleboro, MA 02703 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-09-19 |
| Decision Date | 2015-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08415491150233 | K142667 | 000 |
| 00841549110023 | K142667 | 000 |
| 00841549110030 | K142667 | 000 |
| 00841549110047 | K142667 | 000 |
| 00841549110054 | K142667 | 000 |
| 00841549110061 | K142667 | 000 |
| 00841549110078 | K142667 | 000 |
| 00841549110085 | K142667 | 000 |
| 08415491150158 | K142667 | 000 |
| 08415491150165 | K142667 | 000 |
| 08415491150172 | K142667 | 000 |
| 08415491150189 | K142667 | 000 |
| 08415491150196 | K142667 | 000 |
| 08415491150202 | K142667 | 000 |
| 08415491150226 | K142667 | 000 |
| 00841549110016 | K142667 | 000 |