ASC Abutment AS35-NR61

GUDID 00810157310736

ASC Non-Eng Abut, 4.7mmD-0.5mmL-3.5mmP

Paragon Implant Mfg., LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00810157310736
NIH Device Record Keya81d658e-6549-4f8b-929a-217c520fcc33
Commercial Distribution StatusIn Commercial Distribution
Brand NameASC Abutment
Version Model NumberAS35-NR61
Catalog NumberAS35-NR61
Company DUNS118698566
Company NameParagon Implant Mfg., LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Dimensions

Outer Diameter4.7 Millimeter
Length0.5 Millimeter
Outer Diameter4.7 Millimeter
Length0.5 Millimeter
Outer Diameter4.7 Millimeter
Length0.5 Millimeter
Outer Diameter4.7 Millimeter
Length0.5 Millimeter
Outer Diameter4.7 Millimeter
Length0.5 Millimeter
Outer Diameter4.7 Millimeter
Length0.5 Millimeter
Outer Diameter4.7 Millimeter
Length0.5 Millimeter
Outer Diameter4.7 Millimeter
Length0.5 Millimeter
Outer Diameter4.7 Millimeter
Length0.5 Millimeter
Outer Diameter4.7 Millimeter
Length0.5 Millimeter
Outer Diameter4.7 Millimeter
Length0.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810157310736 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810157310736]

Moist Heat or Steam Sterilization

[00810157310736]

Moist Heat or Steam Sterilization

[00810157310736]

Moist Heat or Steam Sterilization

[00810157310736]

Moist Heat or Steam Sterilization

[00810157310736]

Moist Heat or Steam Sterilization

[00810157310736]

Moist Heat or Steam Sterilization

[00810157310736]

Moist Heat or Steam Sterilization

[00810157310736]

Moist Heat or Steam Sterilization

[00810157310736]

Moist Heat or Steam Sterilization

[00810157310736]

Moist Heat or Steam Sterilization

[00810157310736]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-24
Device Publish Date2025-12-16

On-Brand Devices [ASC Abutment]

00810157312426ASC Eng Abut, 5.7mmD-0.5mmL-4.5mmP
00810157310804ASC Eng Abut, 5.7mmD-2.0mmL-4.5mmP
00810157310798ASC Eng Abut, 5.2mmD-2.0mmL-4.5mmP
00810157310781ASC Eng Abut, 5.2mmD-0.5mmL-4.5mmP
00810157310767ASC Non-Eng Abut, 5.2mmD-2.0mmL-3.5mmP
00810157310750ASC Non-Eng Abut, 5.2mmD-0.5mmL-3.5mmP
00810157310743ASC Non-Eng Abut, 4.7mmD-2.0mmL-3.5mmP
00810157310736ASC Non-Eng Abut, 4.7mmD-0.5mmL-3.5mmP
00810157310729ASC Non-Eng Abut, 3.7mmD-2.0mmL-3.5mmP
00810157310712ASC Non-Eng Abut, 3.7mmD-0.5mmL-3.5mmP
00810157310705ASC Eng Abut, 5.2mmD-2.0mmL-3.5mmP
00810157310699ASC Eng Abut, 5.2mmD-0.5mmL-3.5mmP
00810157310682ASC Eng Abut, 4.7mmD-2.0mmL-3.5mmP
00810157310675ASC Eng Abut, 4.7mmD-0.5mmL-3.5mmP
00810157310668ASC Eng Abut, 3.7mmD-2.0mmL-3.5mmP
00810157310651ASC Eng Abut, 3.7mmD-0.5mmL-3.5mmP
00810157310842ASC Non-Eng Abut, 5.7mmD-2.0mmL-4.5mmP
00810157310835ASC Non-Eng Abut, 5.7mmD-0.5mmL-4.5mmP
00810157310828ASC Non-Eng Abut, 5.2mmD-2.0mmL-4.5mmP
00810157310811ASC Non-Eng Abut, 5.2mmD-0.5mmL-4.5mmP
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