FDA UDI
Not in Commercial Distribution
🇺🇸 United States
iNterra™ iNoffice Nightguard
DI: D00261D0401
·
Model: 61D040
·
DENTSPLY INTERNATIONAL INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- iNterra™ iNoffice Nightguard
- Primary DI
- D00261D0401
- Version / Model
- 61D040
- Catalog Number
- 61D040
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 5
- Public Version Date
- 2024-01-30
- Public Version Status
- Update
- Public Device Record Key
- d2ad0f94-d912-470d-ba40-80bd33c252cf
- Distribution End Date
- 2023-09-06
Device Description
iNterra™ iNoffice Nightguard Refill Package, Large Arch, 6
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQC | Mouthguard, prescription | Unknown | U | |
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38620 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D00261D04062 | HIBCC | Box | 6 | Not in Commercial Distribution | 2023-09-05 |
| Primary | D00261D0401 | HIBCC | ||||
| Unit of Use | D00261D0400 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 6 iNterra™ Nightguard Arches, Large Arch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight.