MUA Plastic Lab. Coping MAPLC

GUDID 00810157311450

MUA Plastic Lab. Coping

Paragon Implant Mfg., LLC

Dental casting wax
Primary Device ID00810157311450
NIH Device Record Key0a63d263-3fc4-4af7-9774-5f7cb7de42b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMUA Plastic Lab. Coping
Version Model NumberMAPLC
Catalog NumberMAPLC
Company DUNS118698566
Company NameParagon Implant Mfg., LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
Phone1-855-649-4365
Emailinfo@paragon-implant.com

Device Dimensions

Outer Diameter4.8 Millimeter
Length12 Millimeter
Outer Diameter4.8 Millimeter
Length12 Millimeter
Outer Diameter4.8 Millimeter
Length12 Millimeter
Outer Diameter4.8 Millimeter
Length12 Millimeter
Outer Diameter4.8 Millimeter
Length12 Millimeter
Outer Diameter4.8 Millimeter
Length12 Millimeter
Outer Diameter4.8 Millimeter
Length12 Millimeter
Outer Diameter4.8 Millimeter
Length12 Millimeter
Outer Diameter4.8 Millimeter
Length12 Millimeter
Outer Diameter4.8 Millimeter
Length12 Millimeter
Outer Diameter4.8 Millimeter
Length12 Millimeter
Outer Diameter4.8 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810157311450 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-15
Device Publish Date2026-01-07

Devices Manufactured by Paragon Implant Mfg., LLC

00810157313331 - NizPlant Insertion Tool2026-02-23 NizPlant Insertion Tool, Long, 23mmL
00810157313775 - NizPlant Insertion Tool2026-02-23 NizPlant Insertion Tool, Short, 19mmL
00810157311566 - NizPlant Transfer2026-02-09 NizPlant NE Transfer, 4.3mmD-3.2mmP
00810157313706 - NizPlant Imp. Center Screw2026-02-09 NizPlant Imp. Center Screw (2 pcs)
00810157313751 - NizPlant Fixation Screw 2026-02-09 NizPlant Fix. Screw, Ex. Short (2 pcs)
00810157314130 - Ext. NizLoc Abutment Screw2026-02-09 Ext. NizLoc Abut Screw, 0.25mmL-4.8mmP
00810157314147 - Ext. NizLoc Abutment Screw2026-02-09 Ext. NizLoc Abut Screw, 1.25mmL-4.8mmP
00810157314154 - Ext. NizLoc Abutment Screw2026-02-09 Ext. NizLoc Abut Screw, 2.25mmL-4.8mmP

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