Lang Dental Mfg. Co., Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Lang Dental Mfg. Co., Inc.” (first 1994, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 115 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 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 7 | 7 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
Review panels
- Dental (9)
Most recent Lang Dental Mfg. Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112397 | ORTHO-JET CRYSTAL | EBI | 2011-11-04 | 77 |
| K100653 | JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD | EBI | 2010-10-08 | 214 |
| K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN | EBG | 2009-06-05 | 219 |
| K081981 | LANG DENTAL ACRYLIC PRIMER | EBI | 2008-11-17 | 129 |
| K081514 | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER | EBI | 2008-09-22 | 115 |
| K081705 | LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN | EBG | 2008-09-17 | 92 |
| K072580 | JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 | EBI | 2007-11-05 | 53 |
| K972553 | LANG DENTAL RESIN A97 FIBRED PINK | EBI | 1997-11-13 | 128 |
| K941925 | ORTHO-JET ACRYLIC RESIN - SPARKLE | EBI | 1994-05-27 | 37 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-06-07.
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.
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.
- Lang Dental Manufacturing Co., Inc. (1 510(k)s)
- Lang Dental Manufacturing Company, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lang Dental Mfg. Co., Inc.?
FDA lists 9 510(k) clearances under the applicant name “Lang Dental Mfg. Co., Inc.” (first 1994, latest 2011), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lang Dental Mfg. Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lang Dental Mfg. Co., Inc. is 115 days.
Which FDA product codes appear under Lang Dental Mfg. Co., Inc.?
The most frequent FDA product codes under this applicant name are EBI (Resin, Denture, Relining, Repairing, Rebasing, 7); EBG (Crown And Bridge, Temporary, Resin, 2).
Next steps
- See all 9 Lang Dental Mfg. Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBI, Lang Dental Mfg. Co., 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.