716369c3515905c52de67b87db149d11
Hygenic Flexi-Dam
COLTENE WHALEDENT, INC.·II·Ecuador ARCSA·Registered July 17, 2018
Device classification
- Risk class
- II
- Product type
- Invasive
- Brand name
- Coltene Whaledent
- Commercial name
- Rubber Dams, for Dentistry
- Sterilization method
- NOT APPLICABLE
Registration information
- Analysis ID
- 716369c3515905c52de67b87db149d11
- Registration date
- July 17, 2018
- Expiration date
- July 17, 2023
- Creation date
- March 02, 2022
Manufacturer
- City
- CUYAHOGA FALLS, OHIO
- Country
- UNITED STATES
- Address
- 235 ASCOT PKWY, CUYAHOGA FALLS OH 44223
Product owner
- Name
- COLTENE WHALEDENT, INC.
- Country
- UNITED STATES
Authorized representative
- Address
- AV. MIGUEL YUNEZ, MANZANA 5, SOLAR 9. BUILDING: ALMAX II OPERATIONS CENTER
- Phone
- 2320319
Product use
NATURAL RUBBER DAM
About this record
Access comprehensive regulatory information for Hygenic Flexi-Dam in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 716369c3515905c52de67b87db149d11 and manufactured by COLTENE WHALEDENT, INC.. The device was registered on July 17, 2018.
This page provides complete registration details including product type (Invasive), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.