FDA UDI
In Commercial Distribution
🇺🇸 United States
Articulating paper/film
DI: D0406020075
·
Model: 60200
·
WHIP-MIX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Articulating paper/film
- Primary DI
- D0406020075
- Version / Model
- 60200
- Catalog Number
- 60200
- Company Name
- WHIP-MIX CORPORATION
- Labeler DUNS
- 006385173
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-24
- Public Version
- 2
- Public Version Date
- 2025-11-06
- Public Version Status
- Update
- Public Device Record Key
- e4332466-da56-4413-9c27-b7ebbe549e62
Device Description
A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device. Ardent™ Exacta-Film Red/Black .00075 75 Strips 19 microns
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 |
|---|---|---|---|---|
| EFH | Paper, Articulation | Dental | 872.6140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16181 | Dental articulation paper | A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D0406020075 | HIBCC |