PANAVIA SA Cement Universal
K-Number: K183537 · 2019-04-25
ApplicantKuraray Noritake Dental, Inc.
Decision Date2019-04-25
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
PANAVIA SA Cement Universal is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2019-04-25 under approval number K183537. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PANAVIA SA Cement Universal?
PANAVIA SA Cement Universal is a medical device that received FDA 510(k) clearance on 2019-04-25. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K183537.
When was PANAVIA SA Cement Universal approved by the FDA?
PANAVIA SA Cement Universal received FDA 510(k) clearance on 2019-04-25, under approval number K183537.
What company makes PANAVIA SA Cement Universal?
PANAVIA SA Cement Universal is manufactured by Kuraray Noritake Dental, Inc..
What is the FDA product code for PANAVIA SA Cement Universal?
The FDA product code for PANAVIA SA Cement Universal is EMA.
Other Devices by Kuraray Noritake Dental, Inc.
K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
K153476KATANA AVENCIA Block
K170834CERABIEN ZR
K170986KATANA Zirconia Block
K191980CLEARFIL MAJESTY ES Flow
K191133KATANA Cleaner, KATANA Cleaner (Trial)
Related Devices (Code: EMA)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.