FDA.reportPublic FDA data

Gutta Percha Points

Primary DI
06970157003961
Brand
Gutta Percha Points
Company
TIANJIN GAPADENT CO., LTD
Model
G22-Gutta Percha Points-GAPA-GIT.04 #45
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
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
06970157003961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970157003961069701570039616970157003961

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
06941974305163Absorbent Paper PointsG22-Absorbent Paper Points-GAPA-GIT.04 #202026-10-30
06970157003916Gutta Percha PointsG22-Gutta Percha Points-GAPA-GIT.04 #202026-10-30
06970157003947Gutta Percha PointsG22-Gutta Percha Points-GAPA-GIT.04 #352026-10-30
06970157003954Gutta Percha PointsG22-Gutta Percha Points-GAPA-GIT.04 #402026-10-30
06970157003978Gutta Percha PointsG22-Gutta Percha Points-GAPA-GIT.04 #502026-10-30
06970157003985Gutta Percha PointsG22-Gutta Percha Points-GAPA-GIT.04 #552026-10-30
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
06941974316343Absorbent Paper PointsG22-Absorbent Paper Points-GAPA-Wave One DMP P2026-08-21
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
06970157003916Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003947Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003954Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003978Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003985Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
08809263708607MX 02-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708614MX 02-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708621MX 02-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708638MX 02-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708645MX 02-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708652MX 02-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708720MX 04-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708737MX 04-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708744MX 04-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708751MX 04-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708768MX 04-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708775MX 04-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708843MX 06-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708850MX 06-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708867MX 06-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708874MX 06-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708881MX 06-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708898MX 06-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708904MG 02-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708911MG 02-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708928MG 02-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708935MG 02-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708942MG 02-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708959MG 02-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263709567MG 04-15Meta Biomed Co., Ltd.EKM2026-10-28