Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KIF — Predicate Candidate Screening
144 FDA 510(k) clearances under this product code; the 50 most recent screened below.
96 daysmedian FDA review time
268 days90th percentile
144clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261415 | Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. | 2026-06-29 | 60 | 0 |
| K253167 | Any-Paste | Mediclus Co., Ltd. | 2026-01-12 | 108 | 0 |
| K252890 | ZenSeal Pro | Kerr Corporation | 2026-01-07 | 118 | 0 |
| K251465 | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd. | 2025-09-25 | 135 | 0 |
| K252285 | Well-Root PT | Vericom Co., Ltd. | 2025-09-19 | 58 | 0 |
| K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd. | 2025-08-22 | 63 | 0 |
| K251390 | MTA vpt | Voco GmbH | 2025-07-03 | 59 | 0 |
| K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | 2025-06-11 | 93 | 0 |
| K243353 | One-Fil Putty | Mediclus Co., Ltd. | 2025-03-14 | 136 | 0 |
| K243546 | AH Plus Endodontic Sealer | Dentsply Sirona, Inc. | 2025-02-13 | 90 | 0 |
| K242934 | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024-12-12 | 78 | 0 |
| K242702 | VioSeal | Spident Co., Ltd. | 2024-11-07 | 59 | 0 |
| K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024-10-03 | 90 | 0 |
| K241457 | Vista BC Putty | Inter-Med, Inc. | 2024-08-28 | 97 | 0 |
| K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MT | Shiva Products | 2024-07-30 | 166 | 0 |
| K240304 | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, | Enpuno Biotechnology Co., Ltd. | 2024-05-28 | 116 | 0 |
| K240365 | Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., Ltd. | 2024-05-10 | 94 | 0 |
| K232182 | One-Fil | Mediclus Co., Ltd. | 2024-01-26 | 186 | 0 |
| K232299 | CeraPutty | Meta Biomed Co., Ltd. | 2023-09-29 | 59 | 0 |
| K231480 | Bright MTA Sealer Plus | Genoss Co., Ltd. | 2023-07-28 | 67 | 0 |
| K231387 | Endofill | Lumendo AG | 2023-07-10 | 59 | 0 |
| K231259 | iRoot SP Plus | Innovative Bioceramix, Inc. | 2023-05-31 | 30 | 0 |
| K230010 | ADSEAL Plus | Meta Biomed Co., Ltd. | 2023-04-13 | 100 | 0 |
| K230797 | SmartMTA Capsule | Sprig Oral Health Technologies, Inc. | 2023-03-24 | 2 | 0 |
| K213757 | Endocem MTA Premixed Regular | Maruchi | 2023-02-14 | 441 | 0 |
| K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fa | Innovative Bioceramix, Inc. | 2022-11-22 | 55 | 0 |
| K221811 | Vista BC Sealer | Inter-Med, Inc. | 2022-11-21 | 152 | 0 |
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical U | Prevest Denpro Limited | 2022-05-23 | 283 | 0 |
| K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., Ltd. | 2021-12-08 | 82 | 0 |
| K211905 | UltraCal XS | Ultradent Products, Inc. | 2021-10-13 | 114 | 0 |
| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g | Septodont | 2021-09-16 | 57 | 0 |
| K211995 | Sonendo Filling Material 5C | Sonendo, Inc. | 2021-08-27 | 60 | 0 |
| K212229 | White Endoseal MTA | Maruchi | 2021-08-13 | 28 | 0 |
| K211799 | Biodentine XP 500, Biodentine XP 200 | Septodont | 2021-08-10 | 61 | 0 |
| K210904 | Metapaste Plus | Meta Biomed Co., Ltd. | 2021-06-30 | 96 | 0 |
| K202617 | Metapex Plus | Meta Biomed Co., Ltd. | 2021-04-14 | 217 | 0 |
| K210333 | DiaPaste | DiaDent Group International | 2021-03-25 | 48 | 0 |
| K202015 | White ENDOSEAL MTA | Maruchi | 2021-03-24 | 246 | 0 |
| K202281 | EDS Bioceramic Sealer (Bioseal) | Essential Dental Systems | 2021-02-12 | 184 | 0 |
| K201222 | Bio-C Repair Ion+ | Angelus Industria DE Produtos Odontologicos S/A | 2021-02-11 | 281 | 0 |
| K200174 | DIA-ROOT BIO MTA | DiaDent Group International | 2020-09-18 | 239 | 0 |
| K200175 | DIA-ROOT BIO Sealer | DiaDent Group International | 2020-06-25 | 154 | 0 |
| K190091 | Diapaste | DiaDent Group International | 2020-03-27 | 434 | 0 |
| K190537 | BIO-C Sealer Ion+ | Angelus Industria DE Produtos Odontologicos S/A | 2019-12-12 | 283 | 0 |
| K182009 | Dia-Proseal | DiaDent Group International | 2019-09-26 | 426 | 0 |
| K190503 | CeraSeal | Meta Biomed Co., Ltd. | 2019-06-07 | 98 | 0 |
| K182625 | Diapex Plus | DiaDent Group International | 2019-06-03 | 252 | 0 |
| K190510 | GuttaSil | Meta Biomed Co., Ltd. | 2019-05-29 | 89 | 0 |
| K181917 | MTA2.3 MATERIALS | NuSmile, Ltd. | 2019-01-11 | 178 | 0 |
| K180199 | BIO-C TEMP | Angelus Industria DE Produtos Odontologicos S/A | 2019-01-04 | 345 | 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