The following data is part of a premarket notification filed by New Stetic with the FDA for New Stetic Dental Amalgam Alloy.
| Device ID | K140125 |
| 510k Number | K140125 |
| Device Name: | NEW STETIC DENTAL AMALGAM ALLOY |
| Classification | Dental Amalgam |
| Applicant | NEW STETIC 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
| Contact | John O'brien |
| Correspondent | John O'brien NEW STETIC 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
| Product Code | OIV |
| Subsequent Product Code | EJJ |
| Subsequent Product Code | ELY |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-16 |
| Decision Date | 2014-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D77810615130 | K140125 | 000 |
| D77810615090 | K140125 | 000 |
| D77810615020 | K140125 | 000 |
| D77810615010 | K140125 | 000 |