510(k) · Cleared
ClearedBredent Novo.Lign a/ Bredent Novo.Lign P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bredent GmbH & Co. KG · ELM Denture, Plastic, Teeth
Cleared on Sep 14, 2010 as substantially equivalent to K962456 (Ivoclar North America, Inc., 1996) after a 151-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 14, 2010
- Review
- 151 days
- Class
- Class II
- Product code
- ELM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962456 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK962456 SR Antaris Anterior Teeth/SR Postaris Posterior TeethIvoclar North America, Inc. · 1996
- This deviceK101064 Bredent Novo.Lign a/ Bredent Novo.Lign PBredent GmbH & Co. KG · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962456 | SR Antaris Anterior Teeth/SR Postaris Posterior Teeth | Ivoclar North America, Inc. | 1996 | — |
| 0 (this device) | K101064 | Bredent Novo.Lign a/ Bredent Novo.Lign P | Bredent GmbH & Co. KG | 2010 | — |
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 ELM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K962456 | SR Antaris Anterior Teeth/SR Postaris Posterior TeethSummary page 1…P Common name: Preformed plastic tooth / artificial PMMA teeth Classification name: Preformed plastic denture tooth, Dental (21 CFR 872.3590 - ELM) Predicate Device: K962456 - SR Antaris anterior teeth/SR Postaris posterior teeth Description of the Device: Bredent novo.lign A/ novo.Iign Partificial a… | 1996 |
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?
- Its one ancestor has no recall.
How does its category compare?
All ELM devicesELM Denture, Plastic, Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ELM
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · ELM
82in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELM
No recall names ELM since 2007.
Adverse event reports per year · ELM
1in 2025
MAUDE reports naming product code ELM, 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 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 125 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 5 | 82 | 0 | 4 |
| 2013 | 2 | — | 0 | 43 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The bredent novo.lign A / novo.lign P are preformed plastic denture teeth as a prefabricated device, composed of materials such as polymethylmethacrylat and methylmethacrylat that are intended for use as veneers. The bredent novoiign A / novo.lign P are used for temporary or partial or full dentures. Permanent veneering: * telescopic and conical crowns * CoCr clasp restorations * crowns and bridges * implant-supported restorations * coverdenture…
Read the full statement (105 words)
The bredent novo.lign A / novo.lign P are preformed plastic denture teeth as a prefabricated device, composed of materials such as polymethylmethacrylat and methylmethacrylat that are intended for use as veneers. The bredent novoiign A / novo.lign P are used for temporary or partial or full dentures.
Permanent veneering:
* telescopic and conical crowns
* CoCr clasp restorations
* crowns and bridges
* implant-supported restorations
* coverdenture techniques
Veneer-up:
* selection of esthetic shade, shape and tooth position
remporary restorations:
* laboratory-made temporaries based on impression and wax-up
* veneer on temporary abutments after placement of the implant
The devices are offered in non-sterile condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101064: Bredent Novo.Lign a/ Bredent Novo.Lign P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101064
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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