Data / Medical devices / Germany / DENTSPLY DETREY GmbH
DENTSPLY DETREY GmbH: FDA-registered device maker in KONSTANZ Baden-Wurttemberg, Germany, 11 510(k) clearances
DENTSPLY DETREY GmbH is registered with the FDA (registration 8010638) in KONSTANZ Baden-Wurttemberg, Germany. It lists 10 device types. The FDA files 11 510(k) clearances under its listings, the newest dated February 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 8010638
- FEI number
- 3004724816
- Address
- Detrey Strasse 1, KONSTANZ Baden-Wurttemberg, Germany, 78467
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- December 28, 1977
- Registered through
- 2026
- Brand names listed
- Adaptable Composite Resin, TPH Spectra ST, Tylok Cement
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Dental Barriers And Sleeves | PEM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2025 | K243546 | AH Plus Endodontic Sealer | KIF | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| November 20, 2018 | K182288 | TPH Spectra ST Flowable Composite Restorative | EBF | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| September 28, 2018 | K181476 | Prime&Bond active Universal Adhesive | KLE | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| September 27, 2016 | K162107 | TPH Spectra+ Universal Composite Restorative | EBF | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| June 7, 2016 | K160232 | Disposable Barrier Sleeves and Covers | PEM | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| March 14, 2007 | K070538 | XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE | KLE | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| April 22, 2005 | K050880 | DYRACT EXTRA RESTORATIVE | EBF | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| June 24, 2004 | K041372 | SMARTLITE PS PEN-STYLE LED CURING LIGHT | EBZ | Substantially Equivalent | Dentsply International | accessdata.fda.gov |
| April 1, 2004 | K040144 | QUIXX POSTERIOR RESTORATIVE | EBF | Substantially Equivalent | Dentsply International | accessdata.fda.gov |
| April 26, 1996 | K960548 | AH PLUS ROOT CANAL SEALER | KIF | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| February 28, 1978 | K780301 | CAULK TYLOK | EMA | Substantially Equivalent | L.D. Caulk Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Agent, Tooth Bonding, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Tooth Shade, Resin
- All makers of Resin, Root Canal Filling
- All makers of Applicator, Resin
- All makers of Cement, Dental
Updated February 13, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.