FDA.reportPublic FDA data

ProFil

Primary DI
07290016787702
Brand
ProFil
Company
SILMET LTD
Model
182A35-P
Catalog number
182A35-P
Device description
Dental Composite
Published
2017-10-22
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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103190000PROFIL COMPOSITES (PROFIL, PROFIL FLOW)Silmet , Ltd.2011-02-02EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016787702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016787702072900167877027290016787702

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600071344
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015358835ProLink1500051500052016-10-26
07290015358842ProLink SE15SEKT15SEKT2016-10-26
07290015358859ProLink15SEUN 15SEUN 2016-11-28
07290016787450ProEtch1901001901002016-10-13
07290016787467ProEtch 1901241901242016-10-13
07290016787474ProEtch1901601901602016-12-19
07290016787627ProLink1500021500022017-10-22
07290012207006Nogama O-110471O-1104712016-10-26
07290012207013Nogama O-110472 O-110472 2016-10-26
07290012207020Nogama O-110473O-1104732016-10-26
07290012207037Nogama O-111471O-1114712016-10-26
07290012207044Nogama O-111472O-1114722016-10-26
07290012207051Nogama O-111473O-1114732016-10-26
07290012207068Nogama O-110491 O-110491 2016-10-26
07290012207075Nogama O-110492 O-110492 2016-10-26
07290012207082Nogama O-110493O-1104932016-10-26
07290012207099Nogama O-111491O-1114912016-10-26
07290012207105Nogama O-111492O-1114922016-10-26
07290012207112Nogama O-111493O-1114932016-10-26
07290012207129Nogama 1194711194712016-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
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