FDA.reportPublic FDA data

Delikit Implant Heavy Body

Primary DI
08800024206288
Brand
Delikit Implant Heavy Body
Company
Sherpakorea
Model
Delikit Implant Heavy Body (50ml*10Cartridges)
Published
2023-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K103346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103346000DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODYSherpa Korea2011-02-11ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800024206288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800024206288088000242062888800024206288

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.

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800024200019Vaccusil Heavy BodyVaccusil Heavy Body (50ml * 4 Cartridges)2017-02-10
08800024200026Vaccusil Heavy Body FSVaccusil Heavy Body FS (50ml * 4 Cartridges)2017-02-10
08800024200033Vaccusil Light BodyVaccusil Light Body (50ml * 4 Cartridges)2017-02-10
08800024200040Vaccusil Light Body FSVaccusil Light Body FS (50ml * 4 Cartridges)2017-02-10
08800024200057Vaccusil Bite RegistrationVaccusil Bite Registration (50ml * 2 Cartridges)2017-02-10
08800024200064Mojo CompleteMojo Complete (2.7ml * 50 Cartridges)2017-02-10
08800024200071Delikit Heavy BodyDelikit Heavy Body (50ml * 2 Cartridges)2017-02-15
08800024200088Delikit Heavy Body FSDelikit Heavy Body FS (50ml * 2 Cartridges)2017-02-15
08800024200095Delikit Regular BodyDelikit Regular Body (50ml * 2 Cartridges)2017-02-15
08800024200101Delikit Medium BodyDelikit Medium Body (50ml * 2 Cartridges)2017-02-15
08800024200118Delikit Light BodyDelikit Light Body (50ml * 2 Cartridges)2017-02-15
08800024200125Delikit Light Body FSDelikit Light Body FS (50ml * 2 Cartridges)2017-02-15
08800024200132Delikit Extra Light BodyDelikit Extra Light Body (50ml * 2 Cartridges)2017-02-15
08800024200149Deli Plant Heavy BodyDeli Plant Heavy Body (50ml * 2 Cartridges)2017-02-15
08800024200156Deli Plant Light BodyDeli Plant Light Body (50ml * 2 Cartridges)2017-02-15
08800024200163Deli DentureDeli Denture (50ml * 2 Cartridges)2017-02-15
08800024200170Delikit Bite RegistrationDelikit Bite Registration (50ml * 2 Cartridges)2017-02-15
08800024200187Deli MaskDeli Mask (50ml * 2 Cartridges)2017-02-15
08800024200194Delikit Putty RSDelikit Putty RS (600ml Set)2017-02-15
08800024200200Delikit Putty FSDelikit Putty FS (600ml Set)2017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081666Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082601Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082991AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083042AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083080AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083134AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083141AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083196AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083202AlginkidMAJOR PRODOTTI DENTARI SPAELW2026-10-20