FDA.reportPublic FDA data

Advance Dental Products

Primary DI
10371347009016
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
GP4T60A
Device description
Gutta Percha .04 Taper #60 Pkg/60
Published
2023-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EKMGUTTA-PERCHA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10371347009016PrimaryGS10
00371347009019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1037134700901610371347009016
00371347009019003713470090193713470090190371347009019

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic gutta-perchaA dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
033505389
Device count
60
Premarket exempt
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00371347022292Advance Dental Products826262026-07-08
00371347023398Advance Dental Products10001212026-07-08
00371347023404Advance Dental Products10001222026-07-08
00371347023411Advance Dental Products10001232026-07-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800069213814Edge One R GPSURE DENT CORPORATIONEKM2026-06-22
08800069213302GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213319GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213326GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213333GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213340GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213357GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213364GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213371GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213388GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213395GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213401GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213418GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213425GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213432GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213449GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213456GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213104Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213111Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213128Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213135Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069204775B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204782B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204799B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069205000B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204805XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204812XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204829XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204836XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204843XP-4DSURE DENT CORPORATIONEKM2025-01-07