iNterra™ iNoffice Nightguard Starter Kit
- Primary DI
- D00261D01062
- Brand
- iNterra™ iNoffice Nightguard Starter Kit
- Company
- DENTSPLY INTERNATIONAL INC.
- Model
- 61D010
- Catalog number
- 61D010
- Device description
- iNterra™ iNoffice Nightguard Starter Kit
- Published
- 2016-09-21
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| MQC | Mouthguard, prescription |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MQC | Mouthguard, Prescription | Unknown | U |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D00261D01062 | Package | HIBCC | 6 | Not in Commercial Distribution |
| D00261D0101 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Custom-made mouthguard | A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Total Volume | 50 | Milliliter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Keep away from sunlight. |
Regulatory Flags
- DUNS number
- 083235549
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| D0013010121 | Ceramco® 3 | Powder Opaque i2/i4 | 301012 | 2016-09-21 |
| D0013010211 | Ceramco® 3 | Powder Opaque D2 | 301021 | 2016-09-21 |
| D0013010311 | Ceramco® 3 | Powder Opaque Modifier Yellow | 301031 | 2016-09-21 |
| D0013010321 | Ceramco® 3 | Powder Opaque Modifier Sienna | 301032 | 2016-09-21 |
| D0013010361 | Ceramco® 3 | Powder Opaque Modifier Pink | 301036 | 2016-09-21 |
| D0013010371 | Ceramco® 3 | Powder Opaque Modifier Ochre | 301037 | 2016-09-21 |
| D0013010481 | Ceramco® 3 | Paste Opaque A3.5 | 301048 | 2016-09-21 |
| D0013010591 | Ceramco® 3 | Paste Opaque C2 | 301059 | 2016-09-21 |
| D0013010701 | Ceramco® 3 | Paste Opaque Modifiers White | 301070 | 2016-09-21 |
| D0013011031 | Ceramco® 3 | Opaceous Dentin i1 | 301103 | 2016-09-21 |
| D0013011071 | Ceramco® 3 | Opaceous Dentin A3.5 | 301107 | 2016-09-21 |
| D0013011101 | Ceramco® 3 | Opaceous Dentin i6 | 301110 | 2016-09-21 |
| D0013011181 | Ceramco® 3 | Opaceous Dentin C2 | 301118 | 2016-09-21 |
| D0013011221 | Ceramco® 3 | Opaceous Dentin D3 | 301122 | 2016-09-21 |
| D0013011501 | Ceramco® 3 | Dentin C4 | 301150 | 2016-09-21 |
| D0013011611 | Ceramco® 3 | Dentin Modifier A3.5 | 301161 | 2016-09-21 |
| D0013011671 | Ceramco® 3 | Dentin Modifier Blue | 301167 | 2016-09-21 |
| D0013012001 | Ceramco® 3 | Natural Enamel White | 301200 | 2016-09-21 |
| D0013012011 | Ceramco® 3 | Natural Enamel Extra Light | 301201 | 2016-09-21 |
| D0013013221 | Ceramco® 3 | Overglaze | 301322 | 2016-09-21 |
Other Devices Sharing Product Codes
dentsplysirona.com