FDA.reportPublic FDA data

Absorbent Paper Points

Primary DI
06941974316343
Brand
Absorbent Paper Points
Company
TIANJIN GAPADENT CO., LTD
Model
G22-Absorbent Paper Points-GAPA-Wave One DMP P
Published
2026-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EKNPoint, Paper, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941974316343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941974316343069419743163436941974316343

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic paper pointA non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.

Regulatory Flags#

DUNS number
545915493
Device count
1
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
true
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
06941974305156Absorbent Paper PointsG22-Absorbent Paper Points-GAPA-GIT.04 #152026-08-21
06941974305170Absorbent Paper PointsG22-Absorbent Paper Points-GAPA-GIT.04 #252026-08-21
06941974305200Absorbent Paper PointsG22-Absorbent Paper Points-GAPA-GIT.04 #402026-08-21
06941974308461Absorbent Paper PointsG22-Absorbent Paper Points-GAPA-GTF 06D2026-08-21
06941974308577Absorbent Paper PointsG50-Absorbent Paper Points-GAPA-ISO #45/802026-08-21
06941974309277Absorbent Paper PointsG22-Absorbent Paper Points-GAPA-GPT F32026-08-21
06941974319764Gutta Percha Points Absorbent Paper PointsG50-Gutta Percha Points Absorbent Paper Points-GAP2026-08-21
06970157003695Gutta Percha PointsG22-Gutta Percha Points-GAPA-ISO #252026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941974305156Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974305170Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974305200Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974308461Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974308577Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974309277Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
06941974319764Gutta Percha Points Absorbent Paper PointsTIANJIN GAPADENT CO., LTDEKN2026-08-21
08800069213463Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213470Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213487Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213494Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213500Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213517Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213524Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213531Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213548Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213555Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213562Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213579Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213586Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213593Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213609Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213616Absorbent Paper PointsSURE DENT CORPORATIONEKN2026-02-09
08800069213142Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213159Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213166Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069213173Edge .04 PPSURE DENT CORPORATIONEKN2025-08-14
08800069204850XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204867XP-4DSURE DENT CORPORATIONEKN2025-01-07
08800069204874XP-4DSURE DENT CORPORATIONEKN2025-01-07