The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for N!ce Lt Glass Ceramic Blocks, N!ce Ht Glass Ceramic Blocks,.
| Device ID | K160262 |
| 510k Number | K160262 |
| Device Name: | N!ce LT Glass Ceramic Blocks, N!ce HT Glass Ceramic Blocks, |
| Classification | Powder, Porcelain |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH Ch-4002 |
| Contact | Christopher Klaczyk |
| Correspondent | Jennifer Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-02 |
| Decision Date | 2016-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031739766 | K160262 | 000 |
| 07630031704511 | K160262 | 000 |
| 07630031704504 | K160262 | 000 |
| 07630031704498 | K160262 | 000 |
| 07630031704481 | K160262 | 000 |
| 07630031704474 | K160262 | 000 |
| 07630031704467 | K160262 | 000 |
| 07630031704450 | K160262 | 000 |
| 07630031704443 | K160262 | 000 |
| 07630031704436 | K160262 | 000 |
| 07630031704429 | K160262 | 000 |
| 07630031704412 | K160262 | 000 |
| 07630031730961 | K160262 | 000 |
| 07630031730954 | K160262 | 000 |
| 07630031730947 | K160262 | 000 |
| 07630031730930 | K160262 | 000 |
| 07630031730923 | K160262 | 000 |
| 07630031770905 | K160262 | 000 |
| 07630031704528 | K160262 | 000 |
| 07630031734617 | K160262 | 000 |
| 07630031739759 | K160262 | 000 |
| 07630031739742 | K160262 | 000 |
| 07630031738707 | K160262 | 000 |
| 07630031738691 | K160262 | 000 |
| 07630031738684 | K160262 | 000 |
| 07630031738677 | K160262 | 000 |
| 07630031738660 | K160262 | 000 |
| 07630031738653 | K160262 | 000 |
| 07630031738646 | K160262 | 000 |
| 07630031738639 | K160262 | 000 |
| 07630031734891 | K160262 | 000 |
| 07630031734853 | K160262 | 000 |
| 07630031734679 | K160262 | 000 |
| 07630031734662 | K160262 | 000 |
| 07630031734655 | K160262 | 000 |
| 07630031734631 | K160262 | 000 |
| 07630031734624 | K160262 | 000 |
| 07630031770899 | K160262 | 000 |