The following data is part of a premarket notification filed by Neo Dental Chemical Products Co., Ltd. with the FDA for Cavios Cavity Liner.
Device ID | K111668 |
510k Number | K111668 |
Device Name: | CAVIOS CAVITY LINER |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. 611 WEST 5TH STREET Austin, TX 78701 |
Contact | Robert Seiple |
Correspondent | Robert Seiple NEO DENTAL CHEMICAL PRODUCTS CO., LTD. 611 WEST 5TH STREET Austin, TX 78701 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-14 |
Decision Date | 2011-08-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04560128312561 | K111668 | 000 |