Calc-I-Oss
FDA 510(k) K042583 · Ultradent Products, Inc.
510(k) numberK042583
Submission
- Device name
- Calc-I-Oss
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- September 22, 2004
- Decision date
- July 19, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYC – Bone Grafting Material, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
Other 510(k)s with product code LYC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253317 | Cytrans ElashieldLYC · Traditional | GC America, Inc. | 07/06/2026SE |
| K253883 | Bonalive MaxillofacialLYC · Special | Bonalive , Ltd. | 05/14/2026SE |
| K251818 | Bontree PlusLYC · Traditional | Hudens Bio Co., Ltd. | 03/06/2026SE |
| K244006 | FG Bone Graft MLYC · Traditional | Full Golden Biotech Co., Ltd. | 09/17/2025SE |
| K243745 | FG Bone Graft BLYC · Traditional | Full Golden Biotech Corporation | 08/29/2025SE |
| K241186 | Synthetic Bone Graft ParticulateLYC · Traditional | Shenzhen Dazhou Medical Technology Co., Ltd. | 02/21/2025SE |
| K213260 | CMFlexTMLYC · Traditional | Dimension Inx Corp. | 12/30/2022SE |
| K202675 | InRoad® Dental Synthetic Bone GraftLYC · Traditional | Osteogene Tech Corp | 03/04/2022SE |
| K201546 | OsOpia Synthetic Bone Void FillerLYC · Traditional | Revisios BV | 10/02/2020SE |
| K201051 | Straumann BoneCeramicLYC · Traditional | Institut Straumann AG | 09/24/2020SE |
More from Institut Straumann AG
| 510(k) | Device | Decision |
|---|---|---|
| K262228 | Transcend Bulk Fill Flowable CompositeEBF · Traditional | 07/01/2026SE |
| K261404 | UltraEZLBH · Special | 04/30/2026SE |
| K240743 | Peak Universal BondKLE · Special | 03/20/2024SE |
| K240694 | FORMA Composite (Shade A3D)EBF · Traditional | 03/15/2024SE |
| K221909 | J-TempEBF · Traditional | 07/01/2022SE |
| K220471 | VALO X, VALO X Accessory LensesEBZ · Traditional | 02/22/2022SE |
| K211905 | UltraCal XSKIF · Traditional | 10/13/2021SE |
| K211237 | UltraTemp Rez IIEMA · Traditional | 07/13/2021SE |
| K210550 | VALO Grand Corded and Accessory LensesEBZ · Traditional | 03/01/2021SE |
| K190627 | VALO Grand CordedEBZ · Special | 04/29/2019SE |
Questions and answers
When was Calc-I-Oss cleared by the FDA?
Calc-I-Oss (K042583) received a 510(k) decision of Substantially Equivalent on July 19, 2005, 300 days after the submission was received.
What is the product code of K042583?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.