FDA 510(k), K972027, ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
FDA 510(k), K972027, ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
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510(K) Number: K972027
Device Name: ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
Manufacturer: ZHERMACK S.P.A.
Device Classification Name: material, impression
Regulation Number: 872.3660
Classification Product Code: ELW
Date Received: 06/02/1997
Decision Date: 07/16/1997
Regulation Medical Specialty: Dental
Device Name: ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
Manufacturer: ZHERMACK S.P.A.
Device Classification Name: material, impression
Regulation Number: 872.3660
Classification Product Code: ELW
Date Received: 06/02/1997
Decision Date: 07/16/1997
Regulation Medical Specialty: Dental
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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