Miles Inc., Dental Products
United StatesFDA applicant, unverified
- Devices
- 2
What Miles Inc., Dental Products makes
Miles Inc. manufactures automated urine chemistry analysis systems, such as the Clinitek Atlas, which performs automated testing of urine samples for clinical diagnostics. The company also produces dental bonding and desensitizing products, including the Gluma 3 Step Bonding System and its associated primer/densitizer.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance pathway. These products are listed in the US regulatory database.
Catalogue
Clinitek Atlas Automated Urine Chemistry System Ref K932674
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Miles Inc., Dental Products have in the registry?
The registry currently lists 2 devices for Miles Inc., Dental Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Miles Inc., Dental Products's devices?
Among its 2 most recently registered devices, Miles Inc., Dental Products has devices listed in FDA 510(k) (2 devices).
What risk classes do Miles Inc., Dental Products's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Miles Inc., Dental Products's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Miles Inc., Dental Products in the registry?
The most recently registered devices listed for Miles Inc., Dental Products include CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM and GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER.