FDA.report

KaVo Spray AMERICA 2113 (Set)

Primary DI
EKAV041196600
Brand
KaVo Spray AMERICA 2113 (Set)
Company
Kaltenbach & Voigt GmbH
Model
0.411.9660
Catalog number
2113 Set
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
EKAV041196600PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental handpiece maintenance unitA device used for the automatic internal cleaning, lubrication and maintenance of dental handpieces used in dentistry (e.g., pneumatically or electrically driven scalers, motors, or turbines). This device will automatically run programs for, e.g., the cleaning and/or lubrication of the internal components with service oil, cleaning water/air spray channels with cleaning fluid and flushing with compressed air after external cleansing, but prior to sterilization. This process will improve performance and safety of the dental instruments. The unit is designed to accept different handpiece models, which are connected directly or via adaptors to the unit's processing chamber.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+18475506800customerservice@kavo.com

Regulatory Flags

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

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