FDA.reportPublic FDA data

PEAKOSIL

Primary DI
08800026400127
Brand
PEAKOSIL
Company
NEOSIL Co., Ltd
Model
NS005P-1
Device description
Product Name: PEAKOSIL One-Time PuttyThis product is a convenience kit of Putty(MSP).This product changed only in packaging materials from Putty.These changes don't cause any change from the original functions of Putty.Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i).
Published
2020-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152180000PEAKNeosil Co., Ltd.2015-10-22ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800026400240PackageGS110In Commercial Distribution
18800026400124PackageGS110In Commercial Distribution
08800026400127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800026400240088000264002408800026400240
1880002640012418800026400124
08800026400127088000264001278800026400127

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690409169
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800026400011PEAKOSILNS033C2017-09-21
08800026400028PEAKOSILMSRC2019-01-07
08800026400080PEAKOSILNS017CF2019-01-07
08800026400097PEAKOSILNS033CF2019-01-07
08800026400004PEAKOSILNS017C2017-09-20
08800026400035PEAKOSILMSBC2019-01-07
08800026400042PEAKOSILMSP2017-09-21
08800026400134PEAKOSILNS005P-22020-01-03
08800026400066PEAKOSILNSSK-12017-09-21
08800026400073PEAKOSILNSSK2017-09-21
18800026400018PEAKOSILNS033C2017-09-21
18800026400025PEAKOSILMSRC2019-01-07
18800026400063PEAKOSILNSSK-12017-09-21
18800026400070PEAKOSILNSSK2017-09-21
18800026400087PEAKOSILNS017CF2019-01-07
18800026400094PEAKOSILNS033CF2019-01-07
08800026400103PEAKOSILNS017T2019-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800024201986Implant Heavy BodySherpakoreaELW2023-08-03
08800024201948Precisil BigSherpakoreaELW2021-06-14
08800024201931Delikit Premium Light BodySherpakoreaELW2021-01-27
08800024201924Precisil Heavy Body FSSherpakoreaELW2021-01-25
08800024201900Delikit Light BodySherpakoreaELW2021-01-07
08800024201917Delikit Light Body FSSherpakoreaELW2021-01-07
08800024201887Delikit Heavy Body FSSherpakoreaELW2021-01-04
08800024201894Delikit Bite RegistrationSherpakoreaELW2021-01-04
08800024201870Delikit Medium BodySherpakoreaELW2020-12-21
08800024201863Deli-Bite ClearSherpakoreaELW2020-10-13
08800024201849Imflex Light BodySherpakoreaELW2020-09-18
08800024201856Imflex Putty RSSherpakoreaELW2020-09-18
08800024201825Jackpot LB FastSherpakoreaELW2020-07-23
08800024201832Jackpot LB FastSherpakoreaELW2020-07-23
08800024201795Delikit Putty RSSherpakoreaELW2020-05-12
08800024201801Delikit Putty FSSherpakoreaELW2020-05-12
08800024201696Delikit Light BodySherpakoreaELW2020-04-29
08800024201702Delikit Light BodySherpakoreaELW2020-04-29
08800024201719Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201726Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201733Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201740Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201757Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201764Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201771Delikit Extra Light BodySherpakoreaELW2020-04-29
08800024201788Delikit Jumbo MonophaseSherpakoreaELW2020-04-29
08800024201665Delikit Heavy BodySherpakoreaELW2020-04-27
08800024201672Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201689Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201580Imflex Heavy BodySherpakoreaELW2020-04-08