3D Endo 3D-GP30

GUDID 00810126504203

Gutta Percha Points Box/120 Vial Pack #30

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Synthetic gutta-percha
Primary Device ID00810126504203
NIH Device Record Key50025d97-8d4d-4734-ae0f-adec4f4ec1c3
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D Endo
Version Model Number3D-GP30
Catalog Number3D-GP30
Company DUNS080194935
Company Name3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com
Phone+1(877)605-8061
Emailcs@3d-dent.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810126504203 [Primary]

FDA Product Code

EKMGUTTA-PERCHA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-28
Device Publish Date2023-02-20

On-Brand Devices [3D Endo]

00810126500625Hedstrom Files NiTi31mm #08 6/Pk
00810126500618Hedstrom Files NiTi 25mm #80 6/Pk
00810126500601Hedstrom Files NiTi 25mm #70 6/Pk
00810126500588Hedstrom Files NiTi 25mm #55 6/Pk
00810126500571Hedstrom Files NiTi 25mm #50 6/Pk
00810126500564Hedstrom Files NiTi 25mm #45-80 6/Pk
00810126500557Hedstrom Files NiTi 25mm #45 6/Pk
00810126500540Hedstrom Files NiTi 25mm #40 6/Pk
00810126500533Hedstrom Files NiTi 25mm #35 6/Pk
00810126500526Hedstrom Files NiTi 25mm #30 6/Pk
00810126500519Hedstrom Files NiTi 25mm #25 6/Pk
00810126500502Hedstrom Files NiTi 25mm #20 6/Pk
00810126500496Hedstrom Files NiTi 25mm #15-40 6/Pk
00810126500489Hedstrom Files NiTi 25mm #15 6/Pk
00810126502537K-File SS 31mm #80 6/Pk
00810126502520K-File SS 31mm #70 6/Pk
00810126502513K-File SS 31mm #60 6/Pk
00810126502506K-File SS 31mm #55 6/Pk
00810126502490K-File SS 31mm #50 6/Pk
00810126502483K-File SS 31mm #45-80 6/Pk
00810126502476K-File SS 31mm #45 6/Pk
00810126502469K-File SS 31mm #40 6/Pk
00810126502452K-File SS 31mm #35 6/Pk
00810126502445K-File SS 31mm #30 6/Pk
00810126504487Gutta Percha Points Box/60/Tapered .06 #35
00810126504463Gutta Percha Points Box/60/Tapered .06 #25
00810126504432Gutta Percha Points Box/60/Tapered .06 #15
00810126504265Gutta Percha Points Box/60/Tapered .04 #15
00810126504258Gutta Percha Points Box/120 Vial Pack #45-80
00810126504234Gutta Percha Points Box/120 Vial Pack #45
00810126504227Gutta Percha Points Box/120 Vial Pack #40
00810126504210Gutta Percha Points Box/120 Vial Pack #35
00810126504203Gutta Percha Points Box/120 Vial Pack #30
00810126504197Gutta Percha Points Box/120 Vial Pack #25
00810126504180Gutta Percha Points Box/120 Vial Pack #20
00810126504173Gutta Percha Points Box/120 Vial Pack #15-40
00810126504166Gutta Percha Points Box/120 Vial Pack #15
00810126504159Gutta Percha Points Vials 60/Pk #140
00810126504142Gutta Percha Points Vials 60/Pk #130
00810126504135Gutta Percha Points Vials 60/Pk #120
00810126504128Gutta Percha Points Vials 60/Pk #110
00810126504111Gutta Percha Points Vials 60/Pk #100
00810126504104Gutta Percha Points Box/120 Vial Pack #10
00810126503299Gutta Percha Points Box/120 #15-40
00810126503282Gutta Percha Points Box/120 #15
00810126503275Gutta Percha Points Box/60/Tapered .06 #40
00810126503268Gutta Percha Points Box/60/Tapered .06 #20
00810126503190Gutta Percha Points Box/60/Tapered .04 #40
00810126503183Gutta Percha Points Box/60/Tapered .04 #35
00810126503138Reamers SS 31mm #80 6/Pk

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.