Salvin Dental Specialties ORATAPE-PLUS-PKG-10
GUDID 00841336128798
Salvin OraTAPE® Plus Resorbable Collagen Wound Dressing - Package of 10
SALVIN DENTAL SPECIALTIES, LLC
General oral wound dressing, animal-derived| Primary Device ID | 00841336128798 |
| NIH Device Record Key | 7c1f2cdc-8639-4391-8ffb-2349ff02c424 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Salvin Dental Specialties |
| Version Model Number | ORATAPE-PLUS-PKG-10 |
| Catalog Number | ORATAPE-PLUS-PKG-10 |
| 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 | true |
| 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 | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com | |
| Phone | 800-535-6566 |
| orders@salvin.com |
Device Dimensions
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
| Width | 25 Millimeter |
| Length | 75 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841336128798 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152600
FDA Product Code
| KGN | Wound Dressing With Animal-Derived Material(S) |
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 | 2025-08-07 |
| Device Publish Date | 2025-07-30 |
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 |
Trademark Results [Salvin Dental Specialties]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SALVIN DENTAL SPECIALTIES 75750997 2426349 Live/Registered |
SALVIN DENTAL SPECIALTIES, INC. 1999-07-16 |
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