Axcent Acrylics 8601030

GUDID D79386010300

Softliner Application Kit

GARRECO, LLC

Denture reliner, soft, professional

• Primary Device ID: D79386010300
• NIH Device Record Key: c107d5a5-8151-4620-88da-b9974edf624c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axcent Acrylics
• Version Model Number: 8601030
• Catalog Number: 8601030
• Company DUNS: 364004762
• Company Name: GARRECO, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D79386010300 [Primary]

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-25

On-Brand Devices [Axcent Acrylics]

• D79386010600: Softliner Gun
• D79386010500: Varnish BandC Kit
• D79386010400: Softliner Primer Kit
• D79386010300: Softliner Application Kit
• D79386010200: Softliner Refill Kit
• D79386010100: Softliner Kit
• D79339200300: ACR MON #6 TRAY LIQUID 1 QT
• D79339200081: ACR MON #6 TRAY LIQUID (8 OZ EACH)
• D79339200041: ACR MON #6 TRAY LIQUID (4 OZ EACH)
• D79339100301: ACR MON #5 POUR TYPE 1 QT
• D79339100081: ACR MON #5 POUR LIQUID (8 OZ EACH)
• D79339100041: ACR MON #5 POUR TYPE (4 OZ EACH)
• D79338600301: ACR MON #4 HI CLARITY SC (QT EACH)
• D79338600081: ACR MON #4 HI CLARITY SC (8 OZ EACH)
• D79338600041: #4 HIC 4oz
• D79338450301: ORTHO LIQ PINK SC (1 QT BTL)
• D79338450081: #3 SC Pink 8oz
• D79338300301: ACR MON #3 SC (QT EACH)
• D79338300081: ACR MON #3 SC (8 OZ EACH)
• D79338300041: ACR MON #3 SC (4 0Z)
• D79338000301: ACR MON #2 15 MIN HC (QT EACH)
• D79338000081: ACR MON #2 15 MIN HC (8 OZ EACH)
• D79337800301: ACR MON #1 HC (QT EACH)
• D79337800081: ACR MON #1 HC (8 OZ EACH)
• D79337800041: #1 HC 4oz
• D79337663200: Ortho Black 20lb
• D79337663051: ORTHO ACR PDR BLACK SC (5# EACH)
• D79337663041: ORTHO ACR PDR BLACK SC (4 OZ EACH)
• D79337663011: ORTHO ACR PDR BLACK SC (1# EACH)
• D79337630200: Ortho White 20lb
• D79337630051: ORTHO ACR PDR WHITE SC (5# EACH)
• D79337630041: ORTHO ACR PDR WHITE SC (4 OZ EACH)
• D79337630011: ORTHO ACR PDR WHITE SC (1# EACH)
• D79337601250: Ortho Clear 25lb 4x3
• D79337601200: Ortho Clear 20lb
• D79337601051: ORTHO ACR PDR CLEAR SC (5# EACH)
• D79337601041: ORTHO ACR PDR CLEAR SC (4 OZ EACH)
• D79337601011: ORTHO ACR PDR CLEAR SC (1# EACH)
• D79337509200: POUR TYPE 909 20lb
• D79337509051: POUR TYPE ACR PDR 09 (909) SC (5# EACH)
• D79337509011: POUR TYPE ACR PDR 09 (909) SC (1# EACH)
• D79337502200: POUR TYPE Lt Fiber 20lb
• D79337502051: POUR TYPE ACR PDR LT FIBER SC (5# EACH)
• D79337502010: POUR TYPE ACR PDR LT FIBER SC (1# EACH)
• D79337388250: 15 MIN 99 25lb
• D79337388200: 15 MIN 99 20lb
• D79337388051: 15 MIN DNT BASE 99 HC (5# EACH)
• D79337388011: 15 MIN DNT BASE 99 HC (1# EACH)
• D79337380200: 15 MIN Pink 20lb
• D79337380051: 15 MIN Pink 5lb