ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
FDA 510(k) clearance K972027 · decided 1997-07-16
Clearance details
- K-number
- K972027
- Device name
- ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
- Applicant
- Zhermack S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-02
- Decision date
- 1997-07-16
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- St Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Imp recall (Z-0811-2013) | Ultradent Products, Inc. | 2013-02-13 |
| Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impres recall (Z-0812-2013) | Ultradent Products, Inc. | 2013-02-13 |