Data / Medical devices / United States / Septodont, Inc
Septodont, Inc: FDA-registered device maker in Lancaster, PA, United States, 4 510(k) clearances
Septodont, Inc is registered with the FDA (registration 3008242564) in Lancaster, PA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 17, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008242564
- Address
- 205 Granite Run Dr., Suite 150, Lancaster, PA, United States, 17601
- Owner or operator
- Septodont (9005668)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 6, 2013
- Registered through
- 2026
- Brand names listed
- Aspiject Self-Asperating Syringe, Synapse Dental Pain Eraser-Home Use, Synapse Dental Pain Eraser-Professional Use and Replacement Tips
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Electrical Dental Anesthesia | LWM | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| January 17, 2020 | K193570 | Dental Pain Eraser | LWM | Substantially Equivalent | Synapse Dental | accessdata.fda.gov |
| January 14, 2020 | K192429 | Dental Pain Eraser | LWM | Substantially Equivalent | Synapse Dental | accessdata.fda.gov |
| December 11, 2009 | K092943 | ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE | EJI | Substantially Equivalent | Arnold Tuber Industries | accessdata.fda.gov |
| October 13, 2000 | K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | EJI | Substantially Equivalent | Ronvig Instruments, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Electrical Dental Anesthesia
- All makers of Syringe, Cartridge
- All makers of Instrument, Filling, Plastic, Dental
Updated January 17, 2020. 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.