Open-Tray Implant Transfer OT35-NR

GUDID 00810157311849

O-Tray NE. Imp. Trans, 4.7mmD-3.5mmP

Paragon Implant Mfg., LLC

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00810157311849
NIH Device Record Keyc396ebb6-e9ec-4a78-ba52-4f3be81d3abd
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpen-Tray Implant Transfer
Version Model NumberOT35-NR
Catalog NumberOT35-NR
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 Diameter4.7 Millimeter
Length11 Millimeter
Outer Diameter4.7 Millimeter
Length11 Millimeter
Outer Diameter4.7 Millimeter
Length11 Millimeter
Outer Diameter4.7 Millimeter
Length11 Millimeter
Outer Diameter4.7 Millimeter
Length11 Millimeter
Outer Diameter4.7 Millimeter
Length11 Millimeter
Outer Diameter4.7 Millimeter
Length11 Millimeter
Outer Diameter4.7 Millimeter
Length11 Millimeter
Outer Diameter4.7 Millimeter
Length11 Millimeter
Outer Diameter4.7 Millimeter
Length11 Millimeter
Outer Diameter4.7 Millimeter
Length11 Millimeter
Outer Diameter4.7 Millimeter
Length11 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810157311849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810157311849]

Moist Heat or Steam Sterilization

[00810157311849]

Moist Heat or Steam Sterilization

[00810157311849]

Moist Heat or Steam Sterilization

[00810157311849]

Moist Heat or Steam Sterilization

[00810157311849]

Moist Heat or Steam Sterilization

[00810157311849]

Moist Heat or Steam Sterilization

[00810157311849]

Moist Heat or Steam Sterilization

[00810157311849]

Moist Heat or Steam Sterilization

[00810157311849]

Moist Heat or Steam Sterilization

[00810157311849]

Moist Heat or Steam Sterilization

[00810157311849]

Moist Heat or Steam Sterilization

[00810157311849]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-16
Device Publish Date2026-01-08

On-Brand Devices [Open-Tray Implant Transfer]

00810157311894O-Tray NE. Imp. Trans, 5.7mmD-4.5mmP
00810157311887O-Tray NE. Imp. Trans, 4.7mmD-4.5mmP
00810157311870O-Tray Eng. Imp. Trans, 5.7mmD-4.5mmP
00810157311863O-Tray Eng. Imp. Trans, 4.7mmD-4.5mmP
00810157311856O-Tray NE. Imp. Trans, 5.7mmD-3.5mmP
00810157311849O-Tray NE. Imp. Trans, 4.7mmD-3.5mmP
00810157311832O-Tray NE. Imp. Trans, 3.7mmD-3.5mmP
00810157311825O-Tray Eng. Imp. Trans, 5.7mmD-3.5mmP
00810157311818O-Tray Eng. Imp. Trans, 4.7mmD-3.5mmP
00810157311801O-Tray Eng. Imp. Trans, 3.7mmD-3.5mmP
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.