The following data is part of a premarket notification filed by Sterngold Dental Llc with the FDA for Era Micro 23 Female Abutment, Era Micro 30 Female Abutment.
| Device ID | K130408 |
| 510k Number | K130408 |
| Device Name: | ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STERNGOLD DENTAL LLC 23 FRANK MOSSBERG DRIVE Attleboro, MA 02703 |
| Contact | Maria Rao |
| Correspondent | Maria Rao STERNGOLD DENTAL LLC 23 FRANK MOSSBERG DRIVE Attleboro, MA 02703 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-19 |
| Decision Date | 2013-07-01 |
| Summary: | summary |