The following data is part of a premarket notification filed by Southern Dental Industries, Ltd. with the FDA for Ice.
| Device ID | K012528 |
| 510k Number | K012528 |
| Device Name: | ICE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SOUTHERN DENTAL INDUSTRIES, LTD. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106 |
| Contact | Samantha J Cheetham |
| Correspondent | Samantha J Cheetham SOUTHERN DENTAL INDUSTRIES, LTD. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3684500211 | K012528 | 000 |
| DO3684000221 | K012528 | 000 |
| DO3684000211 | K012528 | 000 |
| DO3684000191 | K012528 | 000 |
| DO3684000181 | K012528 | 000 |
| DO3684000171 | K012528 | 000 |
| DO3684000161 | K012528 | 000 |
| DO3684000151 | K012528 | 000 |
| DO3684000121 | K012528 | 000 |
| DO3684000111 | K012528 | 000 |
| DO3684000101 | K012528 | 000 |
| DO3684000081 | K012528 | 000 |
| DO3684000071 | K012528 | 000 |
| DO3684000061 | K012528 | 000 |
| DO3684000051 | K012528 | 000 |
| DO3684000041 | K012528 | 000 |
| DO3684000031 | K012528 | 000 |
| DO3684000021 | K012528 | 000 |
| DO3684000231 | K012528 | 000 |
| DO3684001001 | K012528 | 000 |
| DO3684500191 | K012528 | 000 |
| DO3684500181 | K012528 | 000 |
| DO3684500171 | K012528 | 000 |
| DO3684500161 | K012528 | 000 |
| DO3684500151 | K012528 | 000 |
| DO3684500121 | K012528 | 000 |
| DO3684500111 | K012528 | 000 |
| DO3684500101 | K012528 | 000 |
| DO3684500081 | K012528 | 000 |
| DO3684500071 | K012528 | 000 |
| DO3684500061 | K012528 | 000 |
| DO3684500051 | K012528 | 000 |
| DO3684500041 | K012528 | 000 |
| DO3684500031 | K012528 | 000 |
| DO3684500021 | K012528 | 000 |
| DO3684500011 | K012528 | 000 |
| DO3684001031 | K012528 | 000 |
| DO3684000011 | K012528 | 000 |