FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780504085
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
528-50752
Catalog number
528-50752
Device description
Integra® Miltex® Articulating Paper, Thin, Red/Blue, 6PKS
Published
2020-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFHPAPER, ARTICULATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFHPaper, ArticulationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780504085PrimaryGS10
H834528507520SecondaryHIBCC0
00381780504088Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178050408510381780504085
00381780504088003817805040883817805040880381780504088

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulation paperA strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
6
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D040600001ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
D040600011ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
D040600071ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
08906110440175Maarc dental - Articulating PaperSHIVA PRODUCTSEFH2024-10-02
00889813062081Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062098Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062104Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062128Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062135Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062142Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062159Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062166Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062088Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062095Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062101Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062125Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062132Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062149Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062156Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062163Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062173Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
D956OCCLUFL0DSI Occlufoil 6mmD.S.I DENTAL SOLUTIONS LTDEFH2024-07-01
10732224001712Articulating PaperCROSSTEX INTERNATIONAL, INC.EFH2024-04-12
D040600081ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040600130ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040602061ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040600021ARDENT DISPOSABLE DENTWHIP-MIX CORPORATIONEFH2023-08-18
D040600031ARDENT DISPOSABLE DENTWHIP-MIX CORPORATIONEFH2023-08-18
D248720010"Madam Butterfly Silk 3/4"" Blue"HAGER WORLDWIDE, INC.EFH2023-05-15
D248720020"Madam Butterfly Silk 3/4"" Grn"HAGER WORLDWIDE, INC.EFH2023-05-15