ALLO-2.0

GUDID 00841336100244

2.0cc AlloSculpt Demineralized Cortical Putty

Salvin Dental Specialties, Inc.

Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived

• Primary Device ID: 00841336100244
• NIH Device Record Key: 04d00cf4-c228-4d53-b544-f981b8c1b867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLO-2.0
• 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	00841336100244 [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.

• 00841336101760 - Salvin Stainless Steel UNC Probe: 2023-08-29
• 00841336103146 - Replacement Mallet Cap (Set of 2): 2023-08-28
• 00841336103054 - #5 Front Surface Cone Socket Mirror - Box of 12: 2023-08-24
• 00841336102675 - Flexible Stainless Steel Surgical Ruler - 6" (15.25cm): 2023-08-21
• 00841336101128 - Salvin Adson Tissue Forcep-Curved-Serrated 4 3/4": 2023-08-18
• 00841336101135 - Salvin Adson Titanium Curved Tissue Forceps 12cm: 2023-08-18
• 00841336101142 - Salvin Bayonet Elevator Offset "In" - Small: 2023-08-18
• 00841336101159 - Salvin Debakey Atraumatic Tissue Forcep Straight: 2023-08-18