The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Lc Microhybrid.
Device ID | K984484 |
510k Number | K984484 |
Device Name: | LC MICROHYBRID |
Classification | Material, Tooth Shade, Resin |
Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn, DE |
Contact | Jurgen Engelbrecht |
Correspondent | Jurgen Engelbrecht S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn, DE |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-16 |
Decision Date | 1999-01-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850194007701 | K984484 | 000 |
EBIB751011 | K984484 | 000 |
EBIB751001 | K984484 | 000 |
EBIB750121 | K984484 | 000 |
EBIB750091 | K984484 | 000 |
EBIB750081 | K984484 | 000 |
EBIB750071 | K984484 | 000 |
EBIB750051 | K984484 | 000 |
EBIB750041 | K984484 | 000 |
EBIB750031 | K984484 | 000 |
EBIB750021 | K984484 | 000 |
EBIB750011 | K984484 | 000 |
EBIB750001 | K984484 | 000 |
00818207020444 | K984484 | 000 |
00818207020406 | K984484 | 000 |
00818207020376 | K984484 | 000 |
00818207020277 | K984484 | 000 |
00818207020260 | K984484 | 000 |
EBIB751021 | K984484 | 000 |
EBIB751031 | K984484 | 000 |
00850194007695 | K984484 | 000 |
00850194007688 | K984484 | 000 |
00850194007671 | K984484 | 000 |
00850194007664 | K984484 | 000 |
00850194007657 | K984484 | 000 |
00850194007640 | K984484 | 000 |
00850194007633 | K984484 | 000 |
00850194007626 | K984484 | 000 |
00850194007619 | K984484 | 000 |
00850194007602 | K984484 | 000 |
00850194007596 | K984484 | 000 |
00850194007589 | K984484 | 000 |
00850194007572 | K984484 | 000 |
00850194007565 | K984484 | 000 |
00850194007558 | K984484 | 000 |
00850194007541 | K984484 | 000 |
EBIB751041 | K984484 | 000 |
00818207020109 | K984484 | 000 |