ARCHTEK, INC.

FDA Device Registration & Listing · Carmel, IN, US · Registration 1723435

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1723435
FEI Number
3000203342
Entity Name
ARCHTEK, INC.
City/State/Country
Carmel, IN, US
Establishment Address
11405 N. Pennsylvania St., Suite 106, Carmel, IN 46032, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ARCHTEK, INC. (Owner Number: 9025130)
Owner / Operator Contact Address
11405 N Pennsylvania Street, Suite 106, Carmel, IN 46032, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K073446
PMA Number
N/A

All Registered Proprietary Names

Archtek Dental Grind Guard +Sport

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OBR Mouthguard, Over-The-Counter Unknown Class U N/A 2012-11-29

Official Correspondent

Reed Elder

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARCHTEK, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3030268763 OWL DENTAL San Leandro, CA, US
3029913483 DIMEDI KOREA INC Busan, KR
1719513 MEDTECH PRODUCTS, INC. Tarrytown, NY, US
3015525101 MIDWEST TEK New Albany, IN, US
1825660 RANIR LLC Grand Rapids, MI, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1723435. Last updated year: 2026. Please use registration number 1723435 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.