FDA.report

SMARTtorque S609 C

Primary DI
EKAV100816440
Brand
SMARTtorque S609 C
Company
Kaltenbach & Voigt GmbH
Model
1.008.1644
Catalog number
S609 C
Device description
This is a medical device.
Published
2016-09-26
Public version status
Update
Distribution status
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
EFBHANDPIECE, AIR-POWERED, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EKAV100816440PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental power tool system handpiece, pneumaticA hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+18475506800customerservice@kavo.com

Regulatory Flags

DUNS number
332864359
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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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