The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Interim Temp. Crown & Bridge Resin.
Device ID | K833261 |
510k Number | K833261 |
Device Name: | INTERIM TEMP. CROWN & BRIDGE RESIN |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | COE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-23 |
Decision Date | 1984-01-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D6583405911 | K833261 | 000 |
10386040006828 | K833261 | 000 |
10386040006811 | K833261 | 000 |
10386040006804 | K833261 | 000 |
10386040006798 | K833261 | 000 |
10386040006781 | K833261 | 000 |
10386040006774 | K833261 | 000 |
10386040006767 | K833261 | 000 |
10386040006750 | K833261 | 000 |
10386040006743 | K833261 | 000 |
10386040006736 | K833261 | 000 |
10386040006729 | K833261 | 000 |
10386040006712 | K833261 | 000 |
10386040006842 | K833261 | 000 |
D6583405011 | K833261 | 000 |
D6583405261 | K833261 | 000 |
D6583405251 | K833261 | 000 |
D6583405241 | K833261 | 000 |
D6583405231 | K833261 | 000 |
D6583405221 | K833261 | 000 |
D6583405211 | K833261 | 000 |
D6583405161 | K833261 | 000 |
D6583405151 | K833261 | 000 |
D6583405141 | K833261 | 000 |
D6583405131 | K833261 | 000 |
D6583405121 | K833261 | 000 |
D6583405111 | K833261 | 000 |
10386040006705 | K833261 | 000 |