FDA.reportPublic FDA data

Clone Bite

Primary DI
00883205107800
Brand
Clone Bite
Company
ULTRADENT PRODUCTS, INC.
Model
7600
Catalog number
7600
Device description
Clone Bite Kit
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K024034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024034000OCCLUFAST ROCKZhermack S.P.A.2002-12-18ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205107800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205107800008832051078008832051078000883205107800

GMDN Terms#

Term, Definition table
TermDefinition
Dental pit/fissure sealantA resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
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
00883205040398Halo Sectional Matrix System588358832026-06-26
00883205040978Halo Sectional Matrix System588258822026-06-26
00883205044617Halo Sectional Matrix System993199312026-06-26
00883205044624Halo Sectional Matrix System993299322026-06-26
00883205044631Halo Sectional Matrix System993399332026-06-26
00883205044648Halo Sectional Matrix System993599352026-06-26
00883205044655Halo Sectional Matrix System993699362026-06-26
00883205040404Halo Sectional Matrix System588458842026-06-25
00883205004550ViscoStat ClearS646S6462018-04-28
00883205103192ViscoStat Clear641064102018-04-28
00883205103208ViscoStat Clear640964092018-04-28
00883205106889ViscoStat Clear640764072018-04-28
00883205106896ViscoStat Clear640864082018-04-28
00883205045775ClearTemp LC351835182026-04-28
00883205045782ClearTemp LCS3518S35182026-04-28
00883205045805Universal Dentin Sealant2662662026-04-28
00883205045904UltraSealS3529S35292026-04-28
00883205045911Peak Universal BondS4554S45542026-04-28
00883205045928Peak Universal BondS4551S45512026-04-28
00883205044990Porcelain Repair110811082026-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00304040194416Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194423Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194430Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194447Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
07506338322638VIVID JELMDC DENTALELW2026-07-20
07506338322645VIVID JELMDC DENTALELW2026-07-20
07506338322652VIVID JELMDC DENTALELW2026-07-20
07506338322669BLU JELMDC DENTALELW2026-07-20
07506338322676BLU JELMDC DENTALELW2026-07-20
07506338322690VIVID JELMDC DENTALELW2026-07-20
00840456219973JMUJMU DENTAL, INCELW2026-07-07
00840456219980JMUJMU DENTAL, INCELW2026-07-07
00840456219997JMUJMU DENTAL, INCELW2026-07-07
00840456220009JMUJMU DENTAL, INCELW2026-07-07
00840456222232JMUJMU DENTAL, INCELW2026-07-07
00840456222249JMUJMU DENTAL, INCELW2026-07-07
00840456222256JMUJMU DENTAL, INCELW2026-07-07
00840456222263JMUJMU DENTAL, INCELW2026-07-07
00840456222270JMUJMU DENTAL, INCELW2026-07-07
00840456222287JMUJMU DENTAL, INCELW2026-07-07
00840456222294JMUJMU DENTAL, INCELW2026-07-07
00840456222300JMUJMU DENTAL, INCELW2026-07-07
D105VP9008MI4MacImpressSurgimac LLCELW2026-07-06
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021553KROMOPAN SIL putty hard (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021591KROMOPAN SIL light body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021607KROMOPAN SIL regular body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28