Data / Medical devices / United States / Archtek, Inc.
Archtek, Inc.: FDA-registered device maker in Carmel, IN, United States, 2 510(k) clearances
Archtek, Inc. is registered with the FDA (registration 1723435) in Carmel, IN, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 14, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1723435
- FEI number
- 3000203342
- Address
- 11405 N. Pennsylvania St. Suite 106, Carmel, IN, United States, 46032
- Owner or operator
- ARCHTEK, INC. (9025130)
- Roles
- Specification developer
- First device listed
- November 29, 2012
- Registered through
- 2026
- Brand names listed
- Archtek Dental Grind Guard, Archtek Dental Grind Guard +Sport
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mouthguard, Over-The-Counter | OBR | U | Specification developer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 14, 2009 | K090472 | GRIND GUARD | MQC | Substantially Equivalent | Archtek, Inc. | accessdata.fda.gov |
| February 8, 2008 | K073446 | GRIND GUARD | OBR | Substantially Equivalent | Archtek, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 14, 2009. 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.