FDA.reportPublic FDA data

QUATTROcare plus Spray AMERICA 2141 (Set)

Primary DI
EKAV100545240
Brand
QUATTROcare plus Spray AMERICA 2141 (Set)
Company
KaVo Dental GmbH
Model
1.005.4524
Catalog number
AMERICA 2141 Set
Device description
This is a medical device.This is a medical device.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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFBHANDPIECE, AIR-POWERED, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071288000MODIFICATION TO KAVO QUATTROCARESybron Dental Specialties, Inc.2007-07-19EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV100545240PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18475506800customerservice@kavo.com

Regulatory Flags#

DUNS number
333710619
Device count
1
Lot or batch
true
Manufacturing date on label
true

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