FDA UDI
Not in Commercial Distribution
🇺🇸 United States
A2
DI: D798AR1
·
Model: AR
·
RELIANCE ORTHODONTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- A2
- Primary DI
- D798AR1
- Version / Model
- AR
- Catalog Number
- AR
- Company Name
- RELIANCE ORTHODONTIC PRODUCTS INC
- Labeler DUNS
- 113170088
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-07-25
- Public Version
- 3
- Public Version Date
- 2020-07-10
- Public Version Status
- Update
- Public Device Record Key
- cbd95831-a085-4792-85a5-5d3093b0e078
- Distribution End Date
- 2020-07-09
Device Description
The A2 Rectangular Attachment Form can be used for individual tooth movement. Qty 5
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KXR | Applicator, Resin | Dental | 872.3140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42344 | Dental mould | A hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D798AR1 | HIBCC | ||||
| Unit of Use | D798AR0 | HIBCC |
Customer Contacts
- Phone
- 6307734009
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at ambient conditions.