510(k) K252808
- Device
- GlasIonomer FX-LC
- Applicant
- Shofu Dental Corporation
- 510(k) number
- K252808
- Product code
- EMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-09
- Date received
- 2025-09-03
- Regulation
- 872.3275
- Classification name
- Cement, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Malzyner Mauro
- Address
- 1225 Stone Dr. San Marcos CA US 92078 92078
FDA Registration Numbers#
- 1721647
- 9680954
- 3011649314
- 3012421607
- 9680845
- 3013557697
- 2437780
- 9611385
- 3015128224
- 3042244574
- 1000272892
- 2018957
- 2183301
- 1013257
- 3017674095
- 8044164
- 3027241817
- 3026400121
- 3012477813
- 3006694515
- 1723973
- 3005308868
- 9612300
- 9681210
- 3043226252
- 3032378317
- 3014683120
- 3045816931
- 3008524225
- 1000492377
- 3016447764
- 2022039
- 3008320092
- 9614573
- 3006444232
- 3011689956
- 3006805063
- 3014615644
- 3006665149
- 1000486347
- 2086043
- 2024312
- 3012187973
- 3035693034
- 3006367836
- 2280629
- 3004425647
- 1420052
- 3018507299
- 3002808149
- 3008582406
- 3004966444
- 3014579161
- 2523320
- 2244842
- 9680144
- 3005628474
- 2241860
- 3002789526
- 3012627824
- 3016505723
- 3044819802
- 3010864832
- 8030938
- 3004146043
- 3004140838
- 3003120666
- 9613375
- 3032163716
- 2435946
- 3012441963
- 8021851
- 2429849
- 2320721
- 9681356
- 3002807050
- 2511556
- 2126683
- 3009496224
- 3003775534
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EMA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254109 | G-CEM UNIVERSAL | GC America, Inc. | 2026-05-18 |
| 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 |
| 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 |
| K251470 | ResiCem EX | Shofu Dental Corporation | 2025-07-11 |
| K250156 | Choice 2 DC | Bisco, Inc. | 2025-07-11 |
| K250566 | EsCem RMGI | Spident Co., Ltd. | 2025-06-20 |
| K242366 | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | Overfibers S.R.L. | 2025-01-10 |
| K240714 | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | 2024-07-24 |
| K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | 2024-06-28 |
| K240888 | Calibra Abutment Resin Cement | Dentsply Sirona | 2024-04-02 |