N.A.
- Primary DI
- J011074203000
- Brand
- N.A.
- Company
- DENTAURUM GmbH & Co.KG
- Model
- 074-203-00
- Device description
- OrthoSafe sports guard, blue
- Published
- 2016-09-15
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Contact Domains#
dentaurum-us.comProduct Codes#
| Code | Name |
|---|---|
| EEJ | GUARD, DISK |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EEJ | Guard, Disk | Dental | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| J011074203000 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthodontic teeth positioner, preformed | A prefabricated dental device, typically made of plastic, that is an impression of a perfected bite used to prevent a patient's teeth from shifting position, or to move teeth to a final position, after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position. This is a reusable device. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | No special storage conditions required |
Contacts#
| Phone | |
|---|---|
| +1(800)523-3946 | info@dentaurum-us.com |
Regulatory Flags#
- DUNS number
- 315427286
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| J011250001400 | ceraMotion® | 250-001-40 | 2016-09-15 | |
| J011250002200 | ceraMotion® | 250-002-20 | 2016-09-15 | |
| J011250002400 | ceraMotion® | 250-002-40 | 2016-09-15 | |
| J011250003200 | ceraMotion® | 250-003-20 | 2016-09-15 | |
| J011250003400 | ceraMotion® | 250-003-40 | 2016-09-15 | |
| J011250004200 | ceraMotion® | 250-004-20 | 2016-09-15 | |
| J011250004400 | ceraMotion® | 250-004-40 | 2016-09-15 | |
| J011250005200 | ceraMotion® | 250-005-20 | 2016-09-15 | |
| J011250005400 | ceraMotion® | 250-005-40 | 2016-09-15 | |
| J011250006200 | ceraMotion® | 250-006-20 | 2016-09-15 | |
| J011250006400 | ceraMotion® | 250-006-40 | 2016-09-15 | |
| J011250018200 | ceraMotion® | 250-018-20 | 2016-09-15 | |
| J011250019200 | ceraMotion® | 250-019-20 | 2016-09-15 | |
| J011250021200 | ceraMotion® | 250-021-20 | 2016-09-15 | |
| J011250021400 | ceraMotion® | 250-021-40 | 2016-09-15 | |
| J011250022200 | ceraMotion® | 250-022-20 | 2016-09-15 | |
| J011250022400 | ceraMotion® | 250-022-40 | 2016-09-15 | |
| J011250023200 | ceraMotion® | 250-023-20 | 2016-09-15 | |
| J011250023400 | ceraMotion® | 250-023-40 | 2016-09-15 | |
| J011250024200 | ceraMotion® | 250-024-20 | 2016-09-15 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00840326403051 | The Orthodontic Store | Young Innovations, Inc. | EEJ | 2022-11-24 |
| 10840326403058 | The Orthodontic Store | Young Innovations, Inc. | EEJ | 2022-11-24 |
| J01174206000 | N.A. | DENTAURUM GmbH & Co.KG | EEJ | 2018-12-06 |
| J011074000000 | N.A. | DENTAURUM GmbH & Co.KG | EEJ | 2016-09-15 |
| J011074001000 | N.A. | DENTAURUM GmbH & Co.KG | EEJ | 2016-09-15 |
| J011074100000 | N.A. | DENTAURUM GmbH & Co.KG | EEJ | 2016-09-15 |
| J011074101000 | N.A. | DENTAURUM GmbH & Co.KG | EEJ | 2016-09-15 |
| J011074200000 | N.A. | DENTAURUM GmbH & Co.KG | EEJ | 2016-09-15 |
| J011074201000 | N.A. | DENTAURUM GmbH & Co.KG | EEJ | 2016-09-15 |