Devices

Device Recall SybronEndo Elements Obturation Unit;

Model / Serial
Lot/Serial Numbers: 91-17011 to 91-19095; 91-20889 to 91-22339
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Australia, Azerbaijan, Belgium, Canada, China, Cyprus, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Italy, Japan, Kuwait, Latvia, Lebanon, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
Product Description
SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy || The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.
Manufacturer
Ormco/Sybronendo
1 Event
- Recall of Device Recall SybronEndo Elements Obturation Unit;

Manufacturer

Ormco/Sybronendo

Manufacturer Address
Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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