FDA.reportPublic FDA data

Statmatic spray

Primary DI
07640397422035
Brand
Statmatic spray
Company
Dent4You AG
Model
STM500-6NA
Catalog number
STM500-6NA
Device description
One step, pre-sterilization handpiece maintenance spray
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K062418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062418000K-SPRAY, MODEL 085-2715Scican2006-10-19EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17640397422032PackageGS16In Commercial Distribution
07540196002363PreviousGS10
07640397422035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1764039742203217640397422032
07540196002363075401960023637540196002363
07640397422035076403974220357640397422035

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument maintenance lubricantA non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from sunlight.
Storage Environment Temperature0 Degrees Fahrenheit122 Degrees Fahrenheit

Regulatory Flags#

DUNS number
480152811
Device count
1

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07630243662814Alpen Diamonds60032189600321892026-09-04

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