FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Occlusal Reduction Rings 1.5mm Refill 100-pack
DI: 07540172010115
·
Model: 691100
·
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Occlusal Reduction Rings 1.5mm Refill 100-pack
- Primary DI
- 07540172010115
- Version / Model
- 691100
- Catalog Number
- 691100
- Company Name
- CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Labeler DUNS
- 626406016
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-21
- Public Version
- 2
- Public Version Date
- 2022-11-02
- Public Version Status
- Update
- Public Device Record Key
- 7f14862a-1523-44cb-a98a-2386c0851ff9
- Distribution End Date
- 2022-11-01
Device Description
Dental occlusal gauge instrument
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| DZN | INSTRUMENTS, DENTAL HAND | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45240 | Interproximal/occlusal dental gauge, single-use | A device intended to be used to directly measure the interproximal (adjacent) and/or occlusal (opposing) clearance of a prepared tooth, typically to ensure sufficient space in the development of a dental restoration. The device may be in the form of a flexible tab (e.g., thermoplastic material) available in a variety of standard thicknesses. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540172010115 | GS1 |
Customer Contacts
- Phone
- +1(800)265-3444
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 1.5 | Millimeter | |
| Device Size Text, specify | 100 x 1.5mm Reductin Ring |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature