The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Atlantis Crown.
Device ID | K152247 |
510k Number | K152247 |
Device Name: | ATLANTIS Crown |
Classification | Powder, Porcelain |
Applicant | DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
Contact | Helen Lewis |
Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17401 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-10 |
Decision Date | 2016-01-29 |
Summary: | summary |