Heraeus Kulzer, Inc.: FDA filings under this applicant name
FDA lists 166 510(k) clearances under the applicant name “Heraeus Kulzer, Inc.” (first 1988, latest 2013), across 60 product codes in 7 review panels. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 120 |
| 2013 | 1 | 67 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELW | Material, Impression | 21 | 21 |
| KLE | Agent, Tooth Bonding, Resin | 19 | 19 |
| EBF | Material, Tooth Shade, Resin | 18 | 18 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 13 | 13 |
| CGA | Glucose Oxidase, Glucose | 10 | 10 |
| CFR | Hexokinase, Glucose | 6 | 6 |
| LCP | Assay, Glycosylated Hemoglobin | 4 | 4 |
| EJT | Alloy, Gold-Based Noble Metal | 3 | 3 |
| ELM | Denture, Plastic, Teeth | 3 | 3 |
| GKZ | Counter, Differential Cell | 3 | 3 |
Plus 50 more product codes.
Review panels
- Dental (92)
- Clinical Chemistry (50)
- Hematology (10)
- Radiology (6)
- Orthopedic (3)
- Clinical Toxicology (3)
- General and Plastic Surgery (2)
Most recent Heraeus Kulzer, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130647 | XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML | ELW | 2013-05-17 | 67 |
| K123278 | IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF | KLE | 2012-12-07 | 46 |
| K120914 | FLEXITIME FAST & SCAN LIGHT FLOW | ELW | 2012-07-25 | 120 |
| K113574 | FLEXITIME MONOPHASE PRO SCAN | ELW | 2012-07-13 | 224 |
| K112501 | VENUS PEARL PLT REFILL A1 | EBF | 2011-12-14 | 106 |
| K111832 | PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID | EBI | 2011-09-29 | 93 |
| K110037 | PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID | EBI | 2011-04-29 | 113 |
| K102770 | FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW | ELW | 2010-12-21 | 88 |
| K101617 | FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL | ELW | 2010-09-07 | 90 |
| K093575 | GLUMA DESENSITIZER POWER GEL | LBH | 2010-03-05 | 107 |
156 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2014-04-23.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Heraeus Kulzer, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01925040: Comparison of 2 Different Resin Based Filling Materials in Posterior Teeth - a Multicenter Study (Completed, started 2013-06)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Heraeus Lasersonics, Inc. (38 510(k)s)
- Heraeus Medical GmbH (13 510(k)s)
- Heraeus Surgical, Inc. (8 510(k)s)
- Heraeus Kulzer GmbH & Co. KG (4 510(k)s)
- Heraeus Medical Components, LLC (4 510(k)s)
- Heraeus Dental Gold Corp. (3 510(k)s)
- Heraeus Med GmbH (3 510(k)s)
- Heraeus, Inc. (1 510(k)s)
- Heraeus Instruments GmbH (1 510(k)s)
- Heraeus Kulzer, Inc., Dental Products Division (1 510(k)s)
- Heraeus Kulzer, LLC (Mitsui Chemicals Group) (1 510(k)s)
- Heraeus Kulzer, LLC, Mitsui Chemicals Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Heraeus Kulzer, Inc.?
FDA lists 166 510(k) clearances under the applicant name “Heraeus Kulzer, Inc.” (first 1988, latest 2013), across 60 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Heraeus Kulzer, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heraeus Kulzer, Inc. is 76 days.
Which FDA product codes appear under Heraeus Kulzer, Inc.?
The most frequent FDA product codes under this applicant name are ELW (Material, Impression, 21); KLE (Agent, Tooth Bonding, Resin, 19); EBF (Material, Tooth Shade, Resin, 18).
Next steps
- See all 166 Heraeus Kulzer, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ELW, Heraeus Kulzer, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.