iCEM Universal Plus
FDA 510(k) clearance K254063 · decided 2025-12-19
Clearance details
- K-number
- K254063
- Device name
- iCEM Universal Plus
- Applicant
- Kulzer, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-12-17
- Decision date
- 2025-12-19
- Days to decision
- 2 days
- Clearance type
- Abbreviated
- Product code
- EMA
- Device class
- 2
- Regulation number
- 872.3275
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- South Bend, IN, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PacTemp Automix NE (K261937) | The Belport Company Inc., DBA Gingi-Pak | 2026-08-07 |
| DIA-CEM (K261166) | DiaDent Group International | 2026-07-09 |
| G-CEM UNIVERSAL (K254109) | GC America, Inc. | 2026-05-18 |
| REGEN Bioactive Cement (K253337) | Inter-Med, Inc. | 2026-04-15 |
| Bifix Veneer LC, Bifix Veneer Try-In (K252606) | Voco GmbH | 2026-03-20 |
| TopCEM Vigor SA Self-Adhesive Resin Cement (K252785) | Rizhao Huge Biomaterials Company, Ltd. | 2025-12-12 |
| GlasIonomer FX-LC (K252808) | Shofu Dental Corporation | 2025-12-09 |
| ZIRCONOMER P (K252165) | Shofu Dental Corporation | 2025-10-28 |
| EQUIA LC ONE (K250953) | GC America, Inc. | 2025-09-19 |
| RODIN Cement (K251775) | Belport Company, Inc., Gingi-Pak | 2025-09-02 |
| Choice 2 DC (K250156) | Bisco, Inc. | 2025-07-11 |
| ResiCem EX (K251470) | Shofu Dental Corporation | 2025-07-11 |
Recalls involving this device
No recalls on record reference this clearance.