The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Calc-i-oss.
| Device ID | K042583 |
| 510k Number | K042583 |
| Device Name: | CALC-I-OSS |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Tammy Lavery |
| Correspondent | Tammy Lavery ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-22 |
| Decision Date | 2005-07-19 |
| Summary: | summary |