510(k) K844846
- Device
- ESPE KETAC-CEM RADIOPAQUE
- Applicant
- ESPE GMBH (US)
- 510(k) number
- K844846
- Product code
- EMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-03-25
- Date received
- 1984-12-13
- Regulation
- 872.3275
- Classification name
- Cement, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HAROLD A OPOTOW
- Address
- 200 Lake Ave. (#205) Lake Worth FL US 33460 33460
FDA Registration Numbers#
- 3012421607
- 2183301
- 3011649314
- 9680845
- 9681356
- 3006805063
- 3013557697
- 3035693034
- 3011824442
- 3004140838
- 3007210751
- 1000272892
- 3016505723
- 3008912871
- 2022039
- 3018507299
- 3030447506
- 9612300
- 3002789526
- 3022296393
- 3002807050
- 3010419931
- 2018957
- 2433629
- 2429849
- 3004966444
- 8044038
- 3006316962
- 3017674095
- 3015272949
- 1420089
- 1316092
- 2133714
- 3015128224
- 3002807757
- 3038718579
- 8010638
- 3014579161
- 1000492377
- 3005176727
- 1250045
- 8030419
- 3004569445
- 8030938
- 2921595
- 3003120666
- 9681210
- 3009496224
- 1450653
- 2244842
- 3011944170
- 3003621174
- 9615399
- 1000486347
- 3032163716
- 9680144
- 3004425647
- 1424442
- 3004967419
- 2435946
- 2126683
- 3010002722
- 1215305
- 8030067
- 3008582406
- 9616128
- 3012354669
- 3043226252
- 8010908
- 3006367836
- 3014683120
- 3006694515
- 3003449480
- 3010864832
- 3006665149
- 3026400121
- 1013257
- 2511556
- 3005308868
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 |
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases