FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
H834528507501
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
528-50750
Catalog number
528-50750
Device description
Articulating Paper, 12 Packs
Published
2018-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10381780501343PrimaryGS10
H834528507501SecondaryHIBCC0
00381780501346Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178050134310381780501343
00381780501346003817805013463817805013460381780501346

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
081277700
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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
D8371320100Bright SpotTaub ProductsEFH2026-07-16
D8371320200Bright SpotTaub ProductsEFH2026-07-16
D8371320300Bright SpotTaub ProductsEFH2026-07-16
D8371320350Bright SpotTaub ProductsEFH2026-07-16
00840456202395JMUJMU DENTAL, INCEFH2026-07-07
00840456224212JMUJMU DENTAL, INCEFH2026-07-06
00840456224229JMUJMU DENTAL, INCEFH2026-07-06
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