FDA.reportPublic FDA data

Defend

Primary DI
00816577022105
Brand
Defend
Company
YOUNG MYDENT, LLC
Model
PF-1000
Catalog number
PF-1000
Device description
PIT & FISSURE SEALANT KIT
Published
2016-12-13
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
EBCSealant, Pit And Fissure, And Conditioner

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102252000DMP PIT & FISSURE SEALANTDmp, Ltd.2010-12-03EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816577022105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816577022105008165770221058165770221050816577022105

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
081330555
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90816577020395DefendVP-90032016-11-11
90816577020401DefendVP-90082016-11-11
90816577020425DefendMK-71002016-11-03
90816577020449DefendMK-71102016-11-03
90816577020463DefendMK-71202016-11-03
90816577020487DefendMK-72002016-11-07
90816577020500DefendMK-72102016-11-07
90816577020524DefendMK-72202016-11-07
90816577020548DefendMK-73002017-02-02
90816577020562DefendMK-73102016-11-07
90816577020586DefendMK-73202016-11-07
90816577020609DefendMK-74002016-10-26
90816577020623DefendVP-80082016-11-11
90816577020630DefendVP-80062016-11-11
90816577020647DefendVP-90112016-11-11
90816577020654DefendVP-90072016-11-11
90816577020661DefendVP-90102016-11-11
90816577020678DefendVP-90052016-11-11
90816577020685DefendVP-90092016-11-11
90816577020692DefendVP-90042016-11-11

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08806387860068Jet Flow Bulk A2Meta Biomed Co., Ltd.EBC2024-11-16
08806387860075Jet Flow Bulk A3Meta Biomed Co., Ltd.EBC2024-11-16
08806387860136Jet Flow Bulk DentinMeta Biomed Co., Ltd.EBC2024-11-16
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07615208294200Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208294217Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208301335Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2023-04-06
H6686050011iSmileHarry J Bosworth CompanyEBC2023-02-20
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00810111540605Choice 2BISCO INC.EBC2022-08-02
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D757C3900KEU1Choice 2BISCO INC.EBC2021-06-25
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