International Medical Devices Database

Manufacturer Address
Dental EZ Stardental Division, 1816 Colonial Village Ln, Lancaster PA 17601-5891
Source
USFDA
2 Events
- Recall of Device Recall StarDental Classique(TM) Diamond Dental Bur
- Recall of Titan 3 5K LowSpeed Motor

2 devices in the database

Device Recall StarDental Classique(TM) Diamond Dental Bur

Model / Serial
Item 200169, lot numbers 2140459 and 2177284; Item 200174, lot numbers 2151776 and 2158861; Item 200276, lot number 2149190; Item 200288, lot number 2143968; Item 200329, lot number 2139572; Item 200339, lot number 2159105; Item 200354, lot number 2149191; Item 200394, lot number 2164110; Item 200402, lot numbers 2143162 and 2156621; Item 200415, lot number 2139573; Item 200418, lot numbers 2153439, 2163438, 2166502, 2171448, 2173003, and 2175575; Item 200433, lot numbers 2153440 and 2171670; Item 200448, lot numbers 2139574, 2157306, and 2167344; Item 200468, lot number 2151894; Item 200473, lot numbers 2146257, 2156268, and 2166207; Item 200483, lot numbers 2141173, 2151723, and 2161240; Item 200496, lot numbers 2144739, 2151899, 2157307 and 2166208.
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) including the states of CA, FL, IA, IN, NJ, NV, NY, PA, TN, TX, and WI, and the country of Japan.
Product Description
StarDental Classique(TM) Diamond Dental Bur. || Used for specific applications in dental procedures.

Titan 3 5K LowSpeed Motor

Model / Serial
Part number 262261, Lot number 1925391
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution: States of IN and TX
Product Description
Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Dental EZ Stardental Division

2 devices in the database

Device Recall StarDental Classique(TM) Diamond Dental Bur

Titan 3 5K LowSpeed Motor