L.D. Caulk Co.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “L.D. Caulk Co.” (first 1976, latest 1980), plus 1 PMA decision, across 14 product codes in 2 review panels. Median 510(k) review time under this name: 18 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Dentsply Sirona, based on public ownership records.
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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 3 | 3 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 2 |
| EJJ | Alloy, Amalgam | 2 | 2 |
| EMA | Cement, Dental | 2 | 2 |
| EFD | Amalgamator, Dental, Ac-Powered | 1 | 1 |
| EIG | Retractor, All Types | 1 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 1 |
| EJS | Alloy, Other Noble Metal | 1 | 1 |
Plus 4 more product codes.
Review panels
- Dental (18)
- Orthopedic (1)
Most recent L.D. Caulk Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802262 | COMPOSITE RESTORATIVE | — | 1980-09-16 | 0 |
| K801690 | VALIANT | EJJ | 1980-08-13 | 21 |
| K790586 | CHEMBOND | EMA | 1979-05-16 | 50 |
| K790585 | FINESSE | EBF | 1979-05-16 | 50 |
| K780560 | DENTAL AMALGAMATOR | EFD | 1978-04-21 | 16 |
| K780384 | IMPROVED DYCAL | EJK | 1978-03-15 | 6 |
| K780301 | CAULK TYLOK | EMA | 1978-02-28 | 6 |
| K771402 | NUVA-COTE (MODIFICATION TO) | EBC | 1977-08-26 | 28 |
| K771399 | LIP & CHEEK RETRACTOR | EIG | 1977-08-26 | 28 |
| K771398 | SHELL VENEER | ELM | 1977-08-26 | 28 |
10 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N17113 | PMA | OMNIPLASTIC BONE CEMENT | 1981-09-16 |
Recalls
openFDA lists no recalls under a recalling firm named L.D. Caulk Co..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under L.D. Caulk Co.?
FDA lists 20 510(k) clearances under the applicant name “L.D. Caulk Co.” (first 1976, latest 1980), plus 1 PMA decision, across 14 product codes in 2 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 L.D. Caulk Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name L.D. Caulk Co. is 18 days.
Which FDA product codes appear under L.D. Caulk Co.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 3); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 2); EBC (Sealant, Pit And Fissure, And Conditioner, 2).
Next steps
- See all 20 L.D. Caulk Co. clearances with predicates and recalls
- Run predicate analysis for product code EBF, L.D. Caulk Co.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.