Oradapt
GUDID 08800048502519
Absorbable collagen membrane
HYUNDAI BIOLAND Co., Ltd.
Collagen dental regeneration membrane| Primary Device ID | 08800048502519 |
| NIH Device Record Key | bbb23443-5d49-4ab4-bf70-1149158629fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oradapt |
| Version Model Number | OA2030 |
| Company DUNS | 688235061 |
| Company Name | HYUNDAI BIOLAND Co., Ltd. |
| 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 |
Device Dimensions
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
| Length | 30 Millimeter |
| Width | 20 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800048502519 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200623
FDA Product Code
| NPL | Barrier, Animal Source, Intraoral |
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 | 2023-06-23 |
| Device Publish Date | 2023-06-15 |
On-Brand Devices [Oradapt]
| 08800048502526 | Absorbable collagen membrane |
| 08800048502519 | Absorbable collagen membrane |
| 08800048502502 | Absorbable collagen membrane |
Trademark Results [Oradapt]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORADAPT 97685942 not registered Live/Pending |
Intra-Lock Dental Inc. 2022-11-21 |
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