510(k) K254201
- Device
- Any-Cem
- Applicant
- Mediclus Co., Ltd.
- 510(k) number
- K254201
- Product code
- EMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-13
- Date received
- 2025-12-29
- 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
- Ku Da Hyeon
- Address
- # 1210, 134, Gongdan-Ro, Heungdeok-Gu Cheongju-Si KR 28576 28576
FDA Registration Numbers#
- 3003120666
- 1000272892
- 2022039
- 1013257
- 8044164
- 3004967419
- 1723973
- 1721647
- 9614573
- 3012421607
- 8030938
- 9616128
- 8044038
- 3003621174
- 9680954
- 3006644229
- 3043226252
- 1410097
- 3008524225
- 2024312
- 3016505723
- 2411797
- 9612352
- 3011944170
- 3007743883
- 3006316962
- 3002807420
- 1000492377
- 3014683120
- 3006444232
- 9615399
- 3044819802
- 3014615644
- 2437780
- 3012502601
- 2241860
- 2433629
- 9680144
- 3045891668
- 9613375
- 3012441963
- 8010638
- 8030067
- 3010419931
- 3015128224
- 3007210751
- 1413475
- 2515379
- 3002808149
- 3006805063
- 2133714
- 1281412
- 3022296393
- 2921595
- 9681356
- 3030447506
- 3004140838
- 3012996495
- 3013508670
- 3032378317
- 1718912
- 3002807757
- 3012494290
- 2027375
- 3010002722
- 8010908
- 1450653
- 3013557697
- 3031841433
- 1316092
- 3004425647
- 9615414
- 1000486347
- 3026400121
- 3032163716
- 3002807050
- 3005628474
- 2086043
- 3012477813
- 3042272797
Source Documents#
Other 510(k) Records For Product Code EMA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | 2026-08-07 |
| K261166 | DIA-CEM | DiaDent Group International | 2026-07-09 |
| 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 |
| 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 |
| K242366 | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | Overfibers S.R.L. | 2025-01-10 |