510(k) K254109
- Device
- G-CEM UNIVERSAL
- Applicant
- GC America, Inc.
- 510(k) number
- K254109
- Product code
- EMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-18
- Date received
- 2025-12-19
- Regulation
- 872.3275
- Classification name
- Cement, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Futoshi Fusejima
- Address
- 3737 W. 127th St. Alsip IL US 60803 60803
FDA Registration Numbers#
- 3030648980
- 3044819802
- 3002807420
- 3042244574
- 2437780
- 3013557697
- 3006444232
- 1821514
- 3027241817
- 3007210751
- 2086043
- 9681254
- 3026400121
- 2241860
- 9612300
- 1723973
- 9613375
- 3015128224
- 2320721
- 9681356
- 1250045
- 3004140838
- 3003621174
- 1013257
- 1410097
- 2133714
- 3022296393
- 8030067
- 3012996495
- 3006367836
- 3045857207
- 9616128
- 3032163716
- 3012477813
- 3010419931
- 3004967419
- 2511556
- 8021851
- 3015272949
- 9615414
- 1721647
- 2183301
- 3006805063
- 3002807757
- 3011944170
- 3004966444
- 9680845
- 3014683120
- 3005628474
- 3006665149
- 3003120666
- 3011649314
- 9614573
- 3012494290
- 1000272892
- 3012502601
- 3012627824
- 8020994
- 3008912871
- 3004130302
- 9680144
- 8010638
- 3005308868
- 3012354669
- 3010864832
- 3016505723
- 3032378317
- 2515379
- 1000486347
- 3043226252
- 2916735
- 1450653
- 8044038
- 8010908
- 3005176727
- 9612352
- 3003449480
- 2921595
- 3045891668
- 3011689956
Source Documents#
Other 510(k) Records For Product Code EMA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262983 | EsTemp Implant | Spident Co., Ltd. | 2026-09-25 |
| K254201 | Any-Cem | Mediclus Co., Ltd. | 2026-08-13 |
| K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | 2026-08-07 |
| K261166 | DIA-CEM | DiaDent Group International | 2026-07-09 |
| K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | 2026-04-15 |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | 2026-03-20 |
| K254063 | iCEM Universal Plus | Kulzer, LLC | 2025-12-19 |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2025-12-12 |
| K252808 | GlasIonomer FX-LC | Shofu Dental Corporation | 2025-12-09 |
| K252165 | ZIRCONOMER P | Shofu Dental Corporation | 2025-10-28 |
| K250953 | EQUIA LC ONE | GC America, Inc. | 2025-09-19 |
| K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak | 2025-09-02 |
| K250156 | Choice 2 DC | Bisco, Inc. | 2025-07-11 |
| K251470 | ResiCem EX | Shofu Dental Corporation | 2025-07-11 |
| K250566 | EsCem RMGI | Spident Co., Ltd. | 2025-06-20 |