The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Elite H-d Hydrophilic Vinyl Polysiloxane Impression Materials (light Body/normal,light Body/fast Setting,regular Body,).
| Device ID | K972027 |
| 510k Number | K972027 |
| Device Name: | ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) |
| Classification | Material, Impression |
| Applicant | ZHERMACK S.P.A. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Contact | Evan Dick |
| Correspondent | Evan Dick ZHERMACK S.P.A. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1997-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D707562826AN0 | K972027 | 000 |
| DVIV572827AN1 | K972027 | 000 |
| DVIV572828AN1 | K972027 | 000 |
| DVIV572829AN1 | K972027 | 000 |
| DVIV572830AN1 | K972027 | 000 |
| DVIV572831AN1 | K972027 | 000 |
| DVIV573524AN0 | K972027 | 000 |
| DVIV573527AN0 | K972027 | 000 |
| 00883205032249 | K972027 | 000 |
| 00883205032256 | K972027 | 000 |
| 00883205032263 | K972027 | 000 |
| DVIV572826AN1 | K972027 | 000 |
| DVIV572813AN1 | K972027 | 000 |
| D707562852AN0 | K972027 | 000 |
| D707562853AN0 | K972027 | 000 |
| D707562854AN0 | K972027 | 000 |
| D707562855AN0 | K972027 | 000 |
| D707562858AN0 | K972027 | 000 |
| D707562859AN0 | K972027 | 000 |
| D707562862AN0 | K972027 | 000 |
| D707573524EN0 | K972027 | 000 |
| D707573527EN0 | K972027 | 000 |
| DVIV572812AN1 | K972027 | 000 |
| 00883205032270 | K972027 | 000 |
| 00883205032287 | K972027 | 000 |
| 00883205032294 | K972027 | 000 |
| 00883205107688 | K972027 | 000 |
| 00883205107695 | K972027 | 000 |
| 00883205107701 | K972027 | 000 |
| 00883205107718 | K972027 | 000 |
| 00883205107725 | K972027 | 000 |
| 00883205107732 | K972027 | 000 |
| 00883205107756 | K972027 | 000 |
| 00883205107763 | K972027 | 000 |
| 00883205107770 | K972027 | 000 |
| 00883205107787 | K972027 | 000 |
| 00883205107671 | K972027 | 000 |
| 00883205107664 | K972027 | 000 |
| 00883205032300 | K972027 | 000 |
| 00883205032317 | K972027 | 000 |
| 00883205032324 | K972027 | 000 |
| 00883205032331 | K972027 | 000 |
| 00883205032348 | K972027 | 000 |
| 00883205032355 | K972027 | 000 |
| 58033712562051 | K972027 | 000 |
| 58033712562105 | K972027 | 000 |
| 58033712562167 | K972027 | 000 |
| 58033712562198 | K972027 | 000 |
| 00883205107794 | K972027 | 000 |