Advance Dental Products

Primary DI
00850455007310
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
AD00065
Device description
Advance Suture 3-0 Plain Gut C-31 Needle 18"
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZGSUTURE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZGSuture, DentalUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896554000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896554000GUT SUTURESLook, Inc.1990-05-31GAL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850455007317PrimaryGS10
00850455007310Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085045500731710850455007317
00850455007310008504550073108504550073100850455007310

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, plainA single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033505389
Device count
12
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
10850455007249Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007263Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007270Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007287Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007300Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007317Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007324Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007331Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007348Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007355Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007362Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007379Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
10850455007386Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
00850455007266Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
00850455007273Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
00850455007303Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
00850455007327Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
00850455007334Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
00850455007358Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
00850455007365Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08
00850455007372Advance Dental ProductsThe Atlanta Dental Supply CompanyDZG2022-12-08