Closed-Tray Implant Transfer CT35-EN

GUDID 00810157310071

C-Tray Eng. Imp. Trans, 3.7mmD-3.5mmP

Paragon Implant Mfg., LLC

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00810157310071
NIH Device Record Key49023635-9b02-4283-92b5-f277f562300e
Commercial Distribution StatusIn Commercial Distribution
Brand NameClosed-Tray Implant Transfer
Version Model NumberCT35-EN
Catalog NumberCT35-EN
Company DUNS118698566
Company NameParagon Implant Mfg., LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com
Phone1-855-649-4365
Emailinfo@paragon-implant.com

Device Dimensions

Outer Diameter3.7 Millimeter
Length11 Millimeter
Outer Diameter3.7 Millimeter
Length11 Millimeter
Outer Diameter3.7 Millimeter
Length11 Millimeter
Outer Diameter3.7 Millimeter
Length11 Millimeter
Outer Diameter3.7 Millimeter
Length11 Millimeter
Outer Diameter3.7 Millimeter
Length11 Millimeter
Outer Diameter3.7 Millimeter
Length11 Millimeter
Outer Diameter3.7 Millimeter
Length11 Millimeter
Outer Diameter3.7 Millimeter
Length11 Millimeter
Outer Diameter3.7 Millimeter
Length11 Millimeter
Outer Diameter3.7 Millimeter
Length11 Millimeter
Outer Diameter3.7 Millimeter
Length11 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810157310071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810157310071]

Moist Heat or Steam Sterilization


[00810157310071]

Moist Heat or Steam Sterilization


[00810157310071]

Moist Heat or Steam Sterilization


[00810157310071]

Moist Heat or Steam Sterilization


[00810157310071]

Moist Heat or Steam Sterilization


[00810157310071]

Moist Heat or Steam Sterilization


[00810157310071]

Moist Heat or Steam Sterilization


[00810157310071]

Moist Heat or Steam Sterilization


[00810157310071]

Moist Heat or Steam Sterilization


[00810157310071]

Moist Heat or Steam Sterilization


[00810157310071]

Moist Heat or Steam Sterilization


[00810157310071]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-01-16
Device Publish Date2025-12-18

On-Brand Devices [Closed-Tray Implant Transfer]

00810157310965C-Tray Eng. Imp. Trans, 5.7mmD-4.5mmP
00810157310958C-Tray Eng. Imp. Trans, 4.7mmD-4.5mmP
00810157310941C-Tray Eng. Imp. Trans, 5.7mmD-3.5mmP
00810157310934C-Tray Eng. Imp. Trans, 4.7mmD-3.5mmP
00810157310071C-Tray Eng. Imp. Trans, 3.7mmD-3.5mmP

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.