The following data is part of a premarket notification filed by Micerium S.p.a. with the FDA for Tender Ortho Bond-ena Bond-ena Etch.
| Device ID | K072978 |
| 510k Number | K072978 |
| Device Name: | TENDER ORTHO BOND-ENA BOND-ENA ETCH |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | MICERIUM S.P.A. VIA MARCONI 83 Avegno, Genoa, IT 16030 |
| Contact | Eugenio Miceli |
| Correspondent | Eugenio Miceli MICERIUM S.P.A. VIA MARCONI 83 Avegno, Genoa, IT 16030 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-22 |
| Decision Date | 2008-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EMICCOSZ1020 | K072978 | 000 |
| EMICCOS101B0 | K072978 | 000 |
| EMICCOS1010 | K072978 | 000 |
| EMICCFOTX1 | K072978 | 000 |
| EMICCFOTS20 | K072978 | 000 |
| EMICCFOTS1 | K072978 | 000 |
| EMICCFOTS0 | K072978 | 000 |
| EMICCFOTP20 | K072978 | 000 |
| EMICCFOTP1 | K072978 | 000 |
| EMICCFOTP0 | K072978 | 000 |
| EMICCFOTK1 | K072978 | 000 |
| EMICCOSM1011 | K072978 | 000 |
| EMICCOSM101A1 | K072978 | 000 |
| EMICCOSM101B1 | K072978 | 000 |
| EMICCOSZ101 | K072978 | 000 |
| EMICCOSZ1001 | K072978 | 000 |
| EMICCOSZ100 | K072978 | 000 |
| EMICCOSM300P1 | K072978 | 000 |
| EMICCOSM300K1 | K072978 | 000 |
| EMICCOSM300D1 | K072978 | 000 |
| EMICCOSM300D0 | K072978 | 000 |
| EMICCOSM300A20 | K072978 | 000 |
| EMICCOSM300A1 | K072978 | 000 |
| EMICCOSM3001 | K072978 | 000 |
| EMICCFOT1 | K072978 | 000 |