ALLO-3D-1.0

GUDID 00841336100268

1.0cc AlloSculpt-3D Cortical Putty With Chips

Salvin Dental Specialties, Inc.

Bone matrix implant, human-derived

• Primary Device ID: 00841336100268
• NIH Device Record Key: ac938149-e357-44ca-92c1-1c91cb65ed38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLO-3D-1.0
• Version Model Number: Rev A
• Company DUNS: 113344790
• Company Name: Salvin Dental Specialties, Inc.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841336100268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103699

FDA Product Code

• NUN: Bone Grafting Material, Human Source

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-22

Devices Manufactured by Salvin Dental Specialties, Inc.

• 00841336112032 - Salvin: 2024-06-10 Salvin OraMEM® Plus Resorbable Collagen Membrane - 15x20mm
• 00841336112049 - Salvin: 2024-06-07 Salvin OraMEM® Plus Resorbable Collagen Membrane - 20x30mm
• 00841336112056 - Salvin: 2024-06-07 Salvin OraMEM® Plus Resorbable Collagen Membrane - 30x40mm
• 00841336111929 - SALVINOSS-B: 2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material -0.25g (0.54cc) 250-1000 microns
• 00841336111936 - SALVINOSS-B: 2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 0.5g (1.08cc) 250-1000 microns
• 00841336111943 - SALVINOSS-B: 2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0g (2.16cc) 250-1000 microns
• 00841336111950 - SALVINOSS-B: 2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 2.0g(4.32cc) 250-1000 microns
• 00841336111998 - SALVINOSS-B: 2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 0.25 cc 250-1000 microns