Data / Medical devices / United States / Crane Dental Laboratory
Crane Dental Laboratory: FDA-registered device maker in Rochester, NY, United States, 2 510(k) clearances
Crane Dental Laboratory is registered with the FDA (registration 3010324114) in Rochester, NY, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 17, 2019. 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
- 3010324114
- Address
- 3515 Buffalo Rd Suite 30, Rochester, NY, United States, 14624
- Owner or operator
- Crane Dental Laboratory (10044573)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 27, 2013
- Registered through
- 2026
- Brand names listed
- Crane Acrylic Herbst Appliance, EMA, Lamberg SleepWell, Respire Blue Series, Sapphire Dorsal Comfort Fit, Sapphire Herbst Appliance, Tap III Anti-Snoring Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| September 17, 2019 | K181416 | Sapphire Dorsal Comfort Fit | LRK | Substantially Equivalent | Crane Dental Laboratory, Inc. | accessdata.fda.gov |
| September 11, 2014 | K140429 | CRANE ACRYLIC HERBST APPLIANCE | LRK | Substantially Equivalent | Crane Dental Laboratory, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 17, 2019. 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.