FDA UDI
In Commercial Distribution
🇺🇸 United States
Faci Form
DI: D798FFL0
·
Model: FFL
·
RELIANCE ORTHODONTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Faci Form
- Primary DI
- D798FFL0
- Version / Model
- FFL
- Catalog Number
- FFL
- Company Name
- RELIANCE ORTHODONTIC PRODUCTS INC
- Labeler DUNS
- 113170088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-08
- Public Version
- 3
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 627f5a2a-8a21-49aa-89fc-bac196de742b
Device Description
Faci Forms are intended for use as a mold for the creation of temporary, prosthetic composite teeth. This is a pack of 5 medium and 5 large for the left side of the arch. Size #12.
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
- No
- 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 |
|---|---|---|---|---|
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38645 | Dental veneer, professional | A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D798FFL0 | HIBCC |
Customer Contacts
- Phone
- 6307734009
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in ambient conditions.