FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SULLIVAN
DI: D746S2BS1
·
Model: S2-BS
·
DENTSPLY SIRONA ORTHODONTICS INC.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SULLIVAN
- Primary DI
- D746S2BS1
- Version / Model
- S2-BS
- Catalog Number
- S2-BS
- Company Name
- DENTSPLY SIRONA ORTHODONTICS INC.
- Labeler DUNS
- 116903307
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 7
- Public Version Date
- 2024-02-02
- Public Version Status
- Update
- Public Device Record Key
- edd842f0-9b60-4222-bf67-196ddf5dce33
- Distribution End Date
- 2020-03-20
Device Description
SULLIVAN BRUXISM SPLINT CLEAR EACH
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
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KMY | POSITIONER, TOOTH, PREFORMED | Dental | 872.5525 | 1 |
| NXC | Aligner, sequential | Dental | 872.5470 | 2 |
| MQC | Mouthguard, prescription | Unknown | U | |
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45251 | Orthodontic appliance relief material | A device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D746S2BS1 | HIBCC |
Customer Contacts
- Phone
- +1(800)883-8733
- [email protected]