ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
FDA 510(k) clearance K051381 · decided 2005-07-15
Clearance details
- K-number
- K051381
- Device name
- ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
- Applicant
- Ace Surgical Supply Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-27
- Decision date
- 2005-07-15
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LYC
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Brockton, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ace Surgical Supply Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Cytrans™ Elashield (K253317) | GC America, Inc. | 2026-07-06 |
| Bonalive Maxillofacial (K253883) | Bonalive , Ltd. | 2026-05-14 |
| BONTREE PLUS (K251818) | Hudens Bio Co., Ltd. | 2026-03-06 |
| FG Bone Graft M (K244006) | Full Golden Biotech Co., Ltd. | 2025-09-17 |
| FG Bone Graft B (K243745) | Full Golden Biotech Corporation | 2025-08-29 |
| Synthetic Bone Graft Particulate (K241186) | Shenzhen Dazhou Medical Technology Co., Ltd. | 2025-02-21 |
| CMFlexTM (K213260) | Dimension Inx Corp. | 2022-12-30 |
| InRoad® Dental Synthetic Bone Graft (K202675) | Osteogene Tech Corp | 2022-03-04 |
| OsOpia Synthetic Bone Void Filler (K201546) | Revisios BV | 2020-10-02 |
| Straumann BoneCeramic (K201051) | Institut Straumann AG | 2020-09-24 |
| Cytrans Granules (K192597) | GC America, Inc. | 2020-08-17 |
| OSTEON III (K153676) | Genoss Co., Ltd. | 2016-09-14 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Calcium Sulfate Hemihydrate 0.5 gram kits. recall (Z-1805-2010) | Ace Surgical Supply Co., Inc. | 2010-06-16 |
| Calcium Sulfate Hemihydrate 1.0 gram kits. recall (Z-1806-2010) | Ace Surgical Supply Co., Inc. | 2010-06-16 |