FDA.report

Precisil Light Body Fast

Primary DI
08800024201184
Brand
Precisil Light Body Fast
Company
Sherpakorea
Model
Precisil Light Body Fast (50ml * 200Cartridges)
Published
2019-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ELWMaterial, Impression

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800024201184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800024201184088000242011848800024201184

GMDN Terms

TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+827078429961happidenco@naver.com

Regulatory Flags

DUNS number
557822311
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08800024206219SUPPRA Bite RegistrationSUPPRA Bite Registration (50ml * 2 Cartridges)2023-05-22
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