510(k) K254063
- Device
- iCEM Universal Plus
- Applicant
- Kulzer, LLC
- 510(k) number
- K254063
- Product code
- EMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-19
- Date received
- 2025-12-17
- Regulation
- 872.3275
- Classification name
- Cement, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Lucas Harmon
- Address
- 4315 S Lafayette Blvd. South Bend IN US 46614 46614
FDA Registration Numbers#
- 3018507299
- 3010864832
- 3014683120
- 3017674095
- 2523320
- 3006316962
- 8030419
- 2027375
- 2515379
- 1424442
- 2133714
- 2241860
- 1250045
- 3026400121
- 8044038
- 3030648980
- 2022039
- 9613375
- 1420089
- 2126683
- 3003621174
- 9613953
- 3003775534
- 3014615644
- 3006644229
- 8030067
- 3043226252
- 3005628474
- 3032312561
- 3003487388
- 3006444232
- 1420052
- 3002807757
- 3027241817
- 8030938
- 3031841433
- 3007743883
- 3005138409
- 9616128
- 3006367836
- 8044164
- 1000492377
- 1316092
- 3012477813
- 3005176727
- 3042244574
- 3004140838
- 3004130302
- 9615399
- 1410097
- 2183301
- 3010002722
- 3013557697
- 8021851
- 3011649314
- 1413475
- 3006665149
- 3012494290
- 1281412
- 3014579161
- 3013508670
- 1000486347
- 2921595
- 9681356
- 3004146043
- 3010419931
- 3008320092
- 1718912
- 3016505723
- 2411797
- 9680954
- 3016447764
- 3002808149
- 9680144
- 3012187973
- 9612352
- 3012627824
- 3045857207
- 3004966444
- 3013584861
Source Documents#
Other 510(k) Records For Product Code EMA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| 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 |