FDA.reportPublic FDA data

Advance Dental Products

Primary DI
10850455007010
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
43554
Catalog number
SCXSA
Device description
Self Seal Sterilization Pouch 3.5X5.25
Published
2019-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941327000CROSSTEX SELF-SEALING STERILIZATION POUCHCross Country Paper Products Corp.1994-12-22KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850455007017PackageGS110In Commercial Distribution
10850455007010PrimaryGS10
00850455007013Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085045500701720850455007017
1085045500701010850455007010
00850455007013008504550070138504550070130850455007013

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(877)896-7341mm@atlantadental.com

Regulatory Flags#

DUNS number
033505389
Device count
200
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10371347023609Advance Dental Products859-012C2026-04-16
00371347019902Advance Dental Products8000012026-04-16
10371347023111Advance Dental ProductsARA-0012026-04-14
10371347023128Advance Dental ProductsARA-0022026-04-14
10371347023135Advance Dental ProductsARA-0032026-04-14
10371347023142Advance Dental ProductsARA-0042026-04-14
10371347023159Advance Dental ProductsARA-0052026-04-14
10371347023166Advance Dental ProductsARA-0062026-04-14
10371347023173Advance Dental ProductsARA-0072026-04-14
10371347023180Advance Dental ProductsARA-0082026-04-14
10371347023197Advance Dental ProductsARA-0092026-04-14
10371347023203Advance Dental ProductsARA-0102026-04-14
10371347023210Advance Dental ProductsARA-0112026-04-14
10371347023227Advance Dental ProductsARA-0122026-04-14
10371347023234Advance Dental ProductsARA-0132026-04-14
10371347023241Advance Dental ProductsARA-0142026-04-14
10371347023258Advance Dental ProductsARA-0152026-04-14
10371347023265Advance Dental ProductsARA-0162026-04-14
10371347023272Advance Dental ProductsARA-0172026-04-14
10371347023289Advance Dental ProductsARA-0182026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640166769521Z5m(t)-neo InsertZ-Systems AGKCT2026-05-17
07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178117MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344178285MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178353MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178438MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178469MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178506MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178513MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178568MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178629MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178650MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178667MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178698MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177783MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177790MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15