510(k) · Cleared
ClearedMist IC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imagine Milling Technologies, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 1, 2022 as substantially equivalent to K182246 (Imagine Milling Technologies, LLC, 2019) after a 118-day review. Its family tree reaches back 17 generations to 1996. 2 later devices descend from it.
- Decided
- Dec 1, 2022
- Review
- 118 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K960026 (1996). 318 ancestors in all, the oldest K781060 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations between
- 3 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 1 generation backK182246 Mist ICImagine Milling Technologies, LLC · 2019
- This deviceK222368 Mist ICImagine Milling Technologies, LLC · 2022
- Descendant · cites it directly · 1 of its ownK243009 Mist ICImagine Milling Technologies, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK261122 Mist ICImagine Milling Technologies, LLC · 2026
Show all 17 generations
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 16 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 15 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 14 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 10 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 9 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 8 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 7 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 6 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 5 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 4 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 3 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 1 generation backK182246 Mist ICImagine Milling Technologies, LLC · 2019
- This deviceK222368 Mist ICImagine Milling Technologies, LLC · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −16 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −10 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −9 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −8 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −7 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −6 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −5 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −4 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −3 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −1 | K182246 | Mist IC | Imagine Milling Technologies, LLC | 2019 | — |
| 0 (this device) | K222368 | Mist IC | Imagine Milling Technologies, LLC | 2022 | — |
| +1 | K243009 | Mist IC | Imagine Milling Technologies, LLC | 2025 | — |
| +2 | K261122 | Mist IC | Imagine Milling Technologies, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 12 | 0 |
| 1995 | 15 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 19 | 0 |
| 2003 | 17 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 17 | 0 |
| 2007 | 23 | 0 |
| 2008 | 14 | 0 |
| 2009 | 13 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K182246 | Mist ICSummary page 5…phthalmic, Anesthesia, Respiratory, ENT and Dental Devices) Reviewing Division Division Dental and ENT Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K182246, MIST IC, Imagine Milling Technologies, LLC Reference Devices K063341, 3i OSSEOTITE® Certain® Dental Implants, Implant Innovatio… | 2019 |
| † | K063341 | 3I Osseotite Certain Dental Implants | 2007 |
| † | K142260 | NobelActive | 2015 |
| † | K073142 | Nobelreplace Hexagonal Implant | 2008 |
| † | K173418 | NobelParallel Conical Connection | 2019 |
| † | K050705 | Tiunite Implants | 2005 |
| † | K050406 | Nobelspeedy Implants | 2005 |
| † | K050258 | Groovy Implants | 2005 |
| † | K023113 | Replace Tiunite Endosseous Implant | 2002 |
| † | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 |
| † | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243009 | Mist IC | 2025 | 1 |
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 26 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 43 of the 318 ancestors have a recall of any class.
- Of its descendants, K243009 (Imagine Milling Technologies, LLC, 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K182246.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants: Compatible Implant Systems Implant Body Diameter, mm Implant Platform, mm 3.25 3.4 4.0 4.1 Biomet 3i OSSEOTITE® Certain® 5.0 5.0 6.0 6.0 3.5 3.5 (NP)…
Read the full statement (206 words)
MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:
Compatible Implant Systems Implant Body Diameter, mm Implant Platform, mm
3.25 3.4
4.0 4.1
Biomet 3i OSSEOTITE® Certain®
5.0 5.0
6.0 6.0
3.5 3.5 (NP)
NobelActive®
4.3, 5.0 3.9 (RP)
(conical connection)
5.5 5.1 (WP)
3.5 3.5 (NP)
NobelReplace Conical Connection
4.3, 5.0 3.9 (RP)
3.75 3.5 (NP)
NobelParallel Conical Connection 4.3, 5.0 3.9 (RP)
5.5 5.1 (WP)
3.5 3.5 (NP)
4.3 4.3 (RP)
Replace Select Tapered TiUnite
5.0 5.0 (WP)
6.0 6.0
3.5 3.5 (NP)
4.3 4.3 (RP)
Replace Select Tapered PMC
5.0 5.0 (WP)
6.0 6.0
3.5 3.5 (NP)
Replace Select TC
4.0 4.3 (RP)
3.7 3.5
Zimmer Screw-Vent®
4.7 4.5
3.7, 4.1 3.5
Zimmer Tapered Screw-Vent® 4.7 4.5
6.0 5.7
All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.
MIST IC abutments for Biomet 3i Certain 3.25 mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222368 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222368: Mist IC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222368
Report an extraction error
Are you the manufacturer?
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