FDA.report

StarDental Instrument Solutions

Primary DI
D7022661010
Brand
StarDental Instrument Solutions
Company
DENTALEZ, INC.
Model
266101
Device description
Titan EX Motor 20K, 4-Line
Published
2018-11-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7022661010PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental power tool system, pneumaticAn assembly of devices designed to bore and excavate bones, teeth, and tough tissues during a dental surgical procedure. It typically consists of a motorized drill handpiece and/or motor, a control unit, and a variety of attachments used to hold the drilling/excavating instruments (e.g., drill bits, burs, polishing disks). This system is pneumatically-powered (gas-powered), normally by compressed air via a connecting hose to the handpiece/motor. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-866-383-4636xx@xx.xx

Regulatory Flags

DUNS number
059010363
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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D7022625830StarDental Instrument Solutions2625832018-11-05
D7022639720StarDental Instrument Solutions2639722018-11-05

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