510(k) · Cleared
ClearedCalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prevest Denpro Limited · KIF Resin, Root Canal Filling
Cleared on May 23, 2022 as substantially equivalent to K152959 (Sybron Dental Specialties, 2016) and 5 other predicates after a 283-day review. Its family tree reaches back 8 generations to 1999.
- Decided
- May 23, 2022
- Review
- 283 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K990131 (1999). 46 ancestors in all, the oldest K820215 (1982). No later device cites it as a predicate yet.
- Root · 8 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 7 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 6 generations backK032268 MBCPBiomatlante · 2003
- 5 generations backK043005 Modification to MBCPBiomatlante · 2005
- 4 generations backK051885 MBCPBiomatlante · 2005
- 3 generations backK060732 MBCP GelBiomatlante · 2006
- 2 generations backK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- 1 generation backK170175 Endoseal MtaMaruchi · 2018
- This deviceK212563 CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra…Prevest Denpro Limited · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −7 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −6 | K032268 | MBCP | Biomatlante | 2003 | — |
| −5 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −4 | K051885 | MBCP | Biomatlante | 2005 | — |
| −3 | K060732 | MBCP Gel | Biomatlante | 2006 | — |
| −2 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| −1 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| 0 (this device) | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical… | Prevest Denpro Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2004 | 4 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KIF device
- #1 K250710 Injectable Root Canal Bioceramic Sealer (nRoot…score 14.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSummary page 6…apex and MTA Fillapex have a 2 year shelf life). A biocompatibility assessment according to ISO 10993 was provided for all subject devices. Predicate Devices: Sealapex K152959, Vitapex K973667, Endoseal MTA K170175, Pulp Canal Sealer K152956, Roeko Seal Root Canal Sealer K983037, Tubliseal K153067 Refer… | 2016 |
| * | K973667 | Vitapex Pre-Loaded Dental SyringeSummary page 6…apex have a 2 year shelf life). A biocompatibility assessment according to ISO 10993 was provided for all subject devices. Predicate Devices: Sealapex K152959, Vitapex K973667, Endoseal MTA K170175, Pulp Canal Sealer K152956, Roeko Seal Root Canal Sealer K983037, Tubliseal K153067 Reference Devices: Ape… | 1997 |
| * | K170175 | Endoseal MtaSummary page 6…lf life). A biocompatibility assessment according to ISO 10993 was provided for all subject devices. Predicate Devices: Sealapex K152959, Vitapex K973667, Endoseal MTA K170175, Pulp Canal Sealer K152956, Roeko Seal Root Canal Sealer K983037, Tubliseal K153067 Reference Devices: Apexit K893794 (ingredien… | 2018 |
| * | K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWTSummary page 6…ty assessment according to ISO 10993 was provided for all subject devices. Predicate Devices: Sealapex K152959, Vitapex K973667, Endoseal MTA K170175, Pulp Canal Sealer K152956, Roeko Seal Root Canal Sealer K983037, Tubliseal K153067 Reference Devices: Apexit K893794 (ingredients), Adseal K042769 (ingedi… | 2016 |
| * | K983037 | Roeko SealSummary page 6…as provided for all subject devices. Predicate Devices: Sealapex K152959, Vitapex K973667, Endoseal MTA K170175, Pulp Canal Sealer K152956, Roeko Seal Root Canal Sealer K983037, Tubliseal K153067 Reference Devices: Apexit K893794 (ingredients), Adseal K042769 (ingedients), Theracal K063237 (ingredients),… | 1998 |
| * | K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSummary page 6…subject devices. Predicate Devices: Sealapex K152959, Vitapex K973667, Endoseal MTA K170175, Pulp Canal Sealer K152956, Roeko Seal Root Canal Sealer K983037, Tubliseal K153067 Reference Devices: Apexit K893794 (ingredients), Adseal K042769 (ingedients), Theracal K063237 (ingredients), MTA Fillapex K1402… | 2016 |
| † | K893794 | Apexit Root Canal Sealer | 1989 |
| † | K042769 | Adseal Root Canal Sealer | 2004 |
| † | K063237 | Theracal LC | 2006 |
| † | K140247 | Mta Fillapex | 2014 |
| † | K200175 | DIA-ROOT BIO Sealer | 2020 |
| † | K190510 | GuttaSil | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 46 ancestors has a recall of any class.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KIF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KIF
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KIF
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KIF
55in 2025
MAUDE reports naming product code KIF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 4 | 31 | 0 | 2 |
| 2009 | 5 | 94 | 1 | 7 |
| 2010 | 5 | 75 | 0 | 10 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 5 | 172 | 0 | 4 |
| 2013 | 2 | — | 0 | 79 |
| 2014 | 10 | 220 | 0 | 421 |
| 2015 | 1 | — | 0 | 15 |
| 2016 | 5 | 212 | 0 | 5 |
| 2017 | 3 | 211 | 0 | 5 |
| 2018 | 5 | 147 | 0 | 13 |
| 2019 | 7 | 252 | 0 | 6 |
| 2020 | 3 | 239 | 0 | 3 |
| 2021 | 12 | 89 | 0 | 9 |
| 2022 | 3 | 152 | 0 | 10 |
| 2023 | 7 | 59 | 0 | 7 |
| 2024 | 8 | 96 | 0 | 10 |
| 2025 | 7 | 90 | 0 | 55 |
| 2026 | 7 | 108 | 0 | — |
What is it indicated for?
CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points. Calplus is a temporary or permanent root canal filling material for use following pulpectomy, or for apexogenesis or apexification. Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root…
Read the full statement (164 words)
CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points.
Calplus is a temporary or permanent root canal filling material for use following pulpectomy, or for apexogenesis or apexification.
Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
Endoseal is used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.
Nanoseal S is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling.
Zical Ultra Paste is used for permanent obturation of the root canal space with the aid of obturating points.
Zical Ultra Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212563: CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212563
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026