Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EMA — Predicate Candidate Screening
507 FDA 510(k) clearances under this product code; the 50 most recent screened below.
75 daysmedian FDA review time
209 days90th percentile
507clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | 2026-08-07 | 58 | 0 |
| K261166 | DIA-CEM | DiaDent Group International | 2026-07-09 | 91 | 0 |
| K254109 | G-CEM UNIVERSAL | GC America, Inc. | 2026-05-18 | 150 | 0 |
| K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | 2026-04-15 | 197 | 0 |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | 2026-03-20 | 214 | 0 |
| K254063 | iCEM Universal Plus | Kulzer, LLC | 2025-12-19 | 2 | 0 |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2025-12-12 | 101 | 0 |
| K252808 | GlasIonomer FX-LC | Shofu Dental Corporation | 2025-12-09 | 97 | 0 |
| K252165 | ZIRCONOMER P | Shofu Dental Corporation | 2025-10-28 | 110 | 0 |
| K250953 | EQUIA LC ONE | GC America, Inc. | 2025-09-19 | 175 | 0 |
| K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak | 2025-09-02 | 84 | 0 |
| K250156 | Choice 2 DC | Bisco, Inc. | 2025-07-11 | 171 | 0 |
| K251470 | ResiCem EX | Shofu Dental Corporation | 2025-07-11 | 59 | 0 |
| K250566 | EsCem RMGI | Spident Co., Ltd. | 2025-06-20 | 114 | 0 |
| K242366 | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opa | Overfibers S.R.L. | 2025-01-10 | 154 | 0 |
| K240714 | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | 2024-07-24 | 131 | 0 |
| K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | 2024-06-28 | 59 | 0 |
| K240888 | Calibra Abutment Resin Cement | Dentsply Sirona | 2024-04-02 | 1 | 0 |
| K233161 | BeautiLink SA | Shofu Dental Corporation | 2023-09-28 | 1 | 0 |
| K231552 | Dia-Cem | DiaDent Group International | 2023-07-28 | 59 | 0 |
| K214076 | EsCem | Spident Co., Ltd. | 2022-12-19 | 357 | 0 |
| K222253 | GlasIonomer FX ULTRA | Shofu Dental Corporation | 2022-09-22 | 57 | 0 |
| K214118 | Riva Cem Automix | Sdi Limited | 2022-08-30 | 243 | 0 |
| K220640 | Bifix Hybrid Abutment Cement | Voco GmbH | 2022-08-23 | 172 | 0 |
| K213609 | NOVA RESIN dual cure, self adhesive resin cement | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2022-08-09 | 267 | 0 |
| K213201 | DeltaFil, DeltaFil Conditioner | DMG Chemisch-Pharmazeutische Fabrik GmbH | 2022-06-01 | 245 | 0 |
| K210259 | Parkell Self-Adhesive Cement | Parkell, Inc. | 2022-01-20 | 353 | 0 |
| K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass L | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021-11-02 | 258 | 0 |
| K211237 | UltraTemp Rez II | Ultradent Products, Inc. | 2021-07-13 | 78 | 0 |
| K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. | 2021-06-11 | 109 | 0 |
| K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Supe | Prevest Denpro Limited | 2021-05-13 | 436 | 0 |
| K200798 | G-CEM ONE | GC America, Inc. | 2020-11-24 | 243 | 0 |
| K201937 | Ceramir Restore QuikCap | Doxa Dental AB | 2020-11-13 | 123 | 0 |
| K201790 | Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2020-09-29 | 91 | 0 |
| K201856 | Provicol QM Aesthetic | Voco GmbH | 2020-08-26 | 51 | 0 |
| K193260 | U-Cem Premium & MAZIC Cem | Vericom Co., Ltd. | 2020-08-21 | 269 | 0 |
| K193484 | GC Fuji Triage EP | GC America, Inc. | 2020-07-02 | 198 | 0 |
| K192007 | TheraBase, TheraBase Ca | Bisco, Inc. | 2020-03-17 | 232 | 0 |
| K192530 | Surefil one Self-adhesive Composite Hybrid | Dentsply Sirona | 2020-01-23 | 129 | 0 |
| K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | Kettenbach GmbH & Co. KG | 2019-11-08 | 151 | 0 |
| K192992 | Suglue 3 | 3M Deutschland GmbH | 2019-11-05 | 11 | 0 |
| K183465 | Allcem, Allcem Core | Dentscare Ltda | 2019-11-02 | 323 | 0 |
| K191548 | Nexus Universal Self-Cure | Kerr Corporation | 2019-10-11 | 121 | 0 |
| K182854 | GC FujiCEM 2 (Improved) | GC America, Inc. | 2019-07-11 | 274 | 0 |
| K191122 | 3M RelyX Pediatric Resin Modified Glass Ionomer Cement | 3M Espe Dental Products | 2019-05-29 | 30 | 0 |
| K183537 | PANAVIA SA Cement Universal | Kuraray Noritake Dental, Inc. | 2019-04-25 | 127 | 0 |
| K171449 | Metacem | Meta Biomed Co., Ltd. | 2018-05-15 | 363 | 0 |
| K180386 | Meron Plus QM | Voco GmbH | 2018-05-08 | 85 | 0 |
| K172382 | GC Fuji Direct | GC America, Inc. | 2018-04-02 | 237 | 0 |
| K162960 | TotalC-Ram | Itena Clinical | 2017-03-14 | 141 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda