510(k) · Cleared
ClearedCeramaflex Bracket System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tp Orthodontics, Inc. · NJM Bracket, Ceramic, Orthodontic
Cleared on May 3, 1995 after a 61-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 16 later devices descend from it.
- Decided
- May 3, 1995
- Review
- 61 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK950992 Ceramaflex Bracket SystemTp Orthodontics, Inc. · 1995
- Descendant · cites it directly · 15 of its ownK102803 Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
- Descendant · 2 generations on · 6 of its ownK160615 Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK181271 Signature Orthodontic SystemSignature Orthodontics · 2018
- Descendant · 2 generations on · 2 of its ownK163467 C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. · 2017
- Descendant · 4 generations on · 1 of its ownK222764 LightForce Orthodontic SystemLightforce Orthodontics · 2022
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K102803Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011 · cites it directly15descendants
- K160615Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016 · 2 generations on6descendants
- K181271Signature Orthodontic SystemSignature Orthodontics · 2018 · 3 generations on4descendants
- K163467C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. · 2017 · 2 generations on2descendants
- K222764LightForce Orthodontic SystemLightforce Orthodontics · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950992 | Ceramaflex Bracket System | Tp Orthodontics, Inc. | 1995 | — |
| +1 | K102803 | Clarity Advanced Ceramic Brackets | 3M Unitek Corporation | 2011 | — |
| +2 | K160615 | Orthodontic Ceramic Brackets 1.1 | Tomy, Inc. | 2016 | — |
| +3 | K181271 | Signature Orthodontic System | Signature Orthodontics | 2018 | — |
| +2 | K163467 | C-Line Orthodontic Ceramic Bracket | Biocetec Co., Ltd. | 2017 | — |
| +4 | K222764 | LightForce Orthodontic System | Lightforce Orthodontics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NJM? 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 NJM device
- #1 K222764 LightForce Orthodontic Systemscore 8.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102803 | Clarity Advanced Ceramic Brackets | 2011 | 15 |
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?
- Of its descendants, K102803 (3M Unitek Corporation, 2011) has gone furthest, with 15 descendants of its own.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NJM
5in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NJM
1in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NJM
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NJM
1in 2025
MAUDE reports naming product code NJM, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 134 | 0 | 0 |
| 2009 | 4 | 61 | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 4 | 122 | 0 | 1 |
| 2012 | 6 | 90 | 0 | 1 |
| 2013 | 3 | 123 | 1 | 6 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 3 | 234 | 0 | 0 |
| 2016 | 3 | 176 | 0 | 2 |
| 2017 | 3 | 183 | 0 | 2 |
| 2018 | 4 | 76 | 0 | 2 |
| 2019 | 6 | 200 | 0 | 0 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 5 | 1 | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K950992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950992: Ceramaflex Bracket System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950992
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026