Emdogain 075.113
GUDID 07630031700087
Emdogain 0.3 ml Multipack USA, contains 3 syringes Emdogain 0.3 ml, 3 syringes PrefGel 0.6 ml and 6 blunt needles
Institut Straumann AG
Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material| Primary Device ID | 07630031700087 |
| NIH Device Record Key | 3f69de60-ec62-4cef-b3b6-fd5606be2dc5 |
| Commercial Distribution Discontinuation | 2019-02-15 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Emdogain |
| Version Model Number | 1 |
| Catalog Number | 075.113 |
| Company DUNS | 483599259 |
| Company Name | Institut Straumann AG |
| 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 | false |
| 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 | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com |
Device Dimensions
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630031700087 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P930021
FDA Product Code
| NQA | Biologic Material, Dental |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-18 |
| Device Publish Date | 2014-09-24 |
On-Brand Devices [Emdogain]
| 07630031700100 | Straumann® Emdogain 0.7 ml, Enamel Matrix Derivative 30 mg/ml, contains 3 syringes Straumann® |
| 07630031700087 | Emdogain 0.3 ml Multipack USA, contains 3 syringes Emdogain 0.3 ml, 3 syringes PrefGel 0.6 ml an |
| 07630031700025 | Straumann® Emdogain 0.15 ml, Enamel Matrix Derivative 30 mg/ml, contains 5 syringes Straumann® |
Trademark Results [Emdogain]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMDOGAIN 86691528 4901495 Live/Registered |
Straumann Holding AG 2015-07-13 |
 EMDOGAIN 74655961 1990962 Live/Registered |
BIOVENTURES BV 1995-04-04 |
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