Sildent Bite

Primary DI
18809746990076
Brand
Sildent Bite
Company
HRS Co., Ltd.
Model
Bite Registration Material
Published
2020-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181604000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181604000Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent BiteHrs Co., Ltd.2018-11-28ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809746990076PrimaryGS10
08809746990079Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880974699007618809746990076
08809746990079088097469900798809746990079

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature12 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+82316558822shgo@hrssilicone.com

Regulatory Flags#

DUNS number
688000574
Device count
5
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18809746990052Sildent Fast Light BodyDental impression Material2020-12-09
18809746990069Sildent Fast Heavy BodyDental impression Material2020-12-09
08809746990055Sildent Fast Light BodyDental impression Material2020-12-09
08809746990062Sildent Fast Heavy BodyDental impression Material2020-12-09
08809746990079Sildent BiteBite Registration Material2020-12-09
18809746990021Sildent Regular BodyDental impression Material2020-09-09
18809746990038Sildent Heavy BodyDental impression Material2020-09-09
18809746990045Sildent Putty Dental impression Material2020-09-09
18809746990014Sildent Light BodyDental impression Material2020-09-09
08809746990024Sildent Regular BodyDental impression Material2020-09-09
08809746990031Sildent Heavy BodyDental impression Material2020-09-09
08809746990048Sildent Putty Dental impression Material2020-09-09

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18016200011318Mono7LASCOD SPAELW2026-05-27
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