The following data is part of a premarket notification filed by Inter-med / Vista Dental Products with the FDA for Valiant Curing Light.
Device ID | K170101 |
510k Number | K170101 |
Device Name: | Valiant Curing Light |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | Inter-Med / Vista Dental Products 2200 South St. Ste. A Racine, WI 53404 |
Contact | Alex Johnson |
Correspondent | Alex Johnson Inter-Med / Vista Dental Products 2200 South St. Ste. A Racine, WI 53404 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-11 |
Decision Date | 2017-06-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10818207020656 | K170101 | 000 |