The following data is part of a premarket notification filed by New Stetic with the FDA for New Stetic Acrylics.
Device ID | K102874 |
510k Number | K102874 |
Device Name: | NEW STETIC ACRYLICS |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | NEW STETIC 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Contact | Arthur Ward |
Correspondent | Arthur Ward NEW STETIC 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-30 |
Decision Date | 2011-03-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00304040001172 | K102874 | 000 |
00304040001042 | K102874 | 000 |
00304040001035 | K102874 | 000 |
00304040001028 | K102874 | 000 |
00304040001011 | K102874 | 000 |
00304040001004 | K102874 | 000 |
00304040000991 | K102874 | 000 |
00304040000984 | K102874 | 000 |
10304040000868 | K102874 | 000 |
00817610025022 | K102874 | 000 |
00817610023349 | K102874 | 000 |
00304040001059 | K102874 | 000 |
00304040001066 | K102874 | 000 |
00304040001165 | K102874 | 000 |
00304040001158 | K102874 | 000 |
00304040001141 | K102874 | 000 |
00304040001134 | K102874 | 000 |
00304040001127 | K102874 | 000 |
00304040001110 | K102874 | 000 |
00304040001103 | K102874 | 000 |
00304040001097 | K102874 | 000 |
00304040001080 | K102874 | 000 |
00304040001073 | K102874 | 000 |
00817610023332 | K102874 | 000 |