GIBSON HEALTHCARE

GUDID 00366975012210

Gibson Healthcare MTA BioCeramic Root Canal Sealer 9G Syringe

BENCO DENTAL SUPPLY CO.

Endodontic filling/sealing material

• Primary Device ID: 00366975012210
• NIH Device Record Key: 9101afb9-db4b-4c85-980c-bb309b57a218
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GIBSON HEALTHCARE
• Version Model Number: 5245-601
• Company DUNS: 015108087
• Company Name: BENCO DENTAL SUPPLY CO.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com
• Phone: 570-602-6924
• Email: jsoroka@benco.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00366975012210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172701

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-10
• Device Publish Date: 2018-12-10

On-Brand Devices [GIBSON HEALTHCARE]

• 10366975032826: Gibson Healthcare Endo Irrigation Multi-Canal Kit. Contains: (2) 10ml pre-filled sodium hypochlo
• 00366975032812: Gibson Healthcare Endo Irrigation Single Canal Kit. Contains: (1) 10ml pre-filled sodium hypochl
• 00366975013316: 5303-388
• 00366975013309: 5303-351
• 00366975013293: 5303-342
• 00366975013286: 5303-324
• 00366975013279: 5303-306
• 00366975013262: 5303-299
• 00366975013255: 5303-235
• 00366975013248: 5303-226
• 00366975013149: Gibson Healthcare MTA Unidose Pouch Sample
• 00366975013132: Gibson Healthcare MTA White
• 00366975012746: 5251-256
• 00366975012739: 5251-247
• 00366975012722: 5251-238
• 00366975012715: 5251-185
• 00366975012708: 5251-130
• 00366975012692: 5251-096
• 00366975012685: 5251-087
• 00366975012678: 5251-078
• 00366975012661: 5250-944
• 00366975012654: 5250-891
• 00366975012630: Collagen wound dressing, 10 x 20mm
• 00366975012623: Collagen wound dressing, 2 cm x 4 cm x 3 mm
• 00366975012616: Collagen wound dressing, 2.5 cm x 7.5 cm x 1 mm
• 00366975012609: Gibson Healthcare Synthetic Mineral Bone Graft, Particle Size .35-1mm.
• 00366975012593: Gibson Healthcare Synthetic Granules, Synthetic Mineral Bone Graft, Particle Size .35-1mm.
• 00366975012586: Gibson Healthcare Synthetic Granules, Synthetic Mineral Bone Graft, Particle Size .35-1mm.
• 00366975012579: Gibson Healthcare Synthetic Granules, Synthetic Mineral Bone Graft, Particle Size .35-1mm
• 00366975012562: Synthetic Mineral-Collagen Composite Bone Graft. Particle Size Range 11-21um
• 00366975012555: Gibson Healthcare Synthetic Putty, Synthetic Mineral-Collagen Composite Bone Graft. Particle siz
• 00366975012548: Gibson Healthcare Synthetic Putty, Mineral-Collagen Composite Bone Graft. Particle size range 9-
• 00366975012531: Gibson Healthcare Xenograft, Anorganic Bone Graft, 1mm Particle Size, .5cc Syringe.
• 00366975012524: Gibson Healthcare Xenograft, Anorganic Bone Graft, 1mm Particle Size, .5cc Syringe.
• 00366975012517: Gibson Healthcare Xenograft Granules, Anorganic Bone Graft, Particle size .25-1mm.
• 00366975012500: Gibson Healthcare Xenograft Granules, Anorganic Bone Graft, Particle size .25-1mm.
• 00366975012494: Gibson Healthcare Xenograft Granules, Anorganic Bone Graft, Particle Size .25-1mm
• 00366975012487: Gibson Healthcare Xenograft Granules, Anorganic Bone Graft, Particle Size .25-1mm
• 00366975012470: Gibson Healthcare Xenograft Granules, Anorganic Bone Graft, Particle size .25-1mm
• 00366975012463: Gibson Healthcare Xenograft Granules. Anorganic Bone Graft.
• 00366975012456: Gibson Healthcare Membrane 4-6 Regenerative Collagen Dental Membrane
• 00366975012449: Gibson Healthcare Membrane 4-6 Regenerative Collagen Dental Membrane
• 00366975012432: Gibson Healthcare Membrane 4-6 Regenerative Collagen Dental Membrane
• 00366975012425: Gibson Healthcare Seal Regenerative Collagen Dental Membrane
• 00366975012418: Gibson Healthcare Seal Regenerative Collagen Dental Membrane
• 00366975012401: Gibson Healthcare Membrane 3-4 Regenertive Collagen Dental Membrane
• 00366975012395: Gibson Healthcare Membrane 3-4 Regenerative Collagen Dental Membrane
• 00366975012388: Gibson Healthcare Membrane 3-4 Regenerative Collagen Dental Membrane
• 00366975012210: Gibson Healthcare MTA BioCeramic Root Canal Sealer 9G Syringe
• D74440719891: BENCO C3 5-0 BBS 18"/45CM