Salvin Dental Specialties ORASTRUCT-1.0cc

GUDID 00841336138988

Salvin Orastruct® 80/20 TCP/HA Synthetic Graft Material - 1.0cc

SALVIN DENTAL SPECIALTIES, LLC

Collagen dental regeneration membrane

• Primary Device ID: 00841336138988
• NIH Device Record Key: aa8de578-d957-46c3-9521-04ad379c7449
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salvin Dental Specialties
• Version Model Number: ORASTRUCT-1.0cc
• Catalog Number: ORASTRUCT-1.0cc
• Company DUNS: 113344790
• Company Name: SALVIN DENTAL SPECIALTIES, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841336138988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083742

FDA Product Code

• LYC: Bone grafting material, synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-19
• Device Publish Date: 2024-12-11

On-Brand Devices [Salvin Dental Specialties]

• 00841336140035: Peri-Implantitis Bur Kit
• 00841336139121: 6mm Cutting Length Oscillating Blade
• 00841336139114: 5mm Cutting Length Oscillating Blade
• 00841336139107: 15mm Cutting Length Oscillating Blade
• 00841336139091: 10mm Cutting Length Oscillating Blade
• 00841336139008: Salvin Orastruct® 80/20 TCP/HA Synthetic Graft Material - 0.5cc In Syringe - Package of 5
• 00841336138995: Salvin Orastruct® 80/20 TCP/HA Synthetic Graft Material - 2.5cc
• 00841336138988: Salvin Orastruct® 80/20 TCP/HA Synthetic Graft Material - 1.0cc
• 00841336138780: OsseoFiber Demineralized Cortical Fibers - 2.5cc
• 00841336137363: Silicon Guards for Molt Mouth Gag-Child
• 00841336136229: OraGRAFT® Mineralized Cancellous Bone - 2.00cc - 250-1000 microns
• 00841336128729: Perio Chisel
• 00841336126381: Basic Bone Spreading System
• 00841336126329: Sinus Comp Kit Aqua Tip 4.5
• 00841336126312: Sinus Comp Kit Aqua Tip 4.2
• 00841336126305: Sinus Comp Kit Aqua Tip 4.0
• 00841336126299: Sinus Comp Kit Aqua Tip 3.8
• 00841336126282: Sinus Comp Kit Aqua Tip 3.5
• 00841336126275: Sinus Comp Kit Aqua Tip 3.3
• 00841336126268: Sinus Comp Kit Aqua Tip 3.0
• 00841336126251: Sinus Comp Kit Aqua Tip 2.8
• 00841336126244: Adapter for the Sinus Comp Kit
• 00841336126237: Aqua System for the Sinus Comp Kit
• 00841336126213: Lateral Reamer 6.5x3mm
• 00841336126206: Lateral Reamer 6.5x2mm
• 00841336126190: Sinus 8 mm Stopper
• 00841336126183: Sinus 7 mm Stopper
• 00841336126176: Sinus 6 mm Stopper
• 00841336126169: Sinus 5 mm Stopper
• 00841336126152: Sinus 4 mm Stopper
• 00841336126145: Sinus 3 mm Stopper
• 00841336126138: Sinus 2 mm Stopper
• 00841336126121: Sinus 1 mm Stopper
• 00841336126008: 4.2 Crest Reamer
• 00841336125995: 3.8 Crest Reamer
• 00841336125988: 3.3 Crest Reamer
• 00841336125971: 2.8 Crest Reamer
• 00841336125841: Meisinger 13mm Diameter Diamond Saw Disc
• 00841336125834: Meisinger 10mm Diameter Diamond Saw Disc
• 00841336125827: DIAMOND DISC, 7.0MM DIAMOND COATED OSTEOTOMY SAW, EXTRA FINE GRIT, HP
• 00841336125810: Meisinger 7mm Diameter Diamond Saw Disc
• 00841336125759: 250mg SalvinOss with Collagen
• 00841336125735: 100mg SalvinOss with Collagen
• 00841336125728: SalvinOss® Xenograft Bone Graft Material - 2.50 cc (1.25g) - 250-1000 microns
• 00841336125711: SalvinOss® Xenograft Bone Graft Material - 1.00 cc (0.5g) - 250-1000 microns
• 00841336125704: SalvinOss® Xenograft Bone Graft Material - 0.50 cc (0.25g) - 250-1000 microns
• 00841336125599: Safe Relax® Angled Tip For Posterior Teeth
• 00841336125582: Safe Relax® Flat Hook Tip With Non Slip Grip
• 00841336125575: Safe Relax® Hook Tip For Bridges
• 00841336125568: Safe Relax® Straight Tip For Anterior Teeth