FDA UDI
In Commercial Distribution
🇺🇸 United States
Nordent Manufacturing, Inc.
DI: 00840018674554
·
Model: oppln3-4
·
NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nordent Manufacturing, Inc.
- Primary DI
- 00840018674554
- Version / Model
- oppln3-4
- Catalog Number
- Nordent Hygiene Catalogue
- Company Name
- NORDENT MANUFACTURING INC
- Labeler DUNS
- 053187985
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-14
- Public Version
- 1
- Public Version Date
- 2026-03-23
- Public Version Status
- New
- Public Device Record Key
- 12a061a8-762b-4345-a131-bcbad9bb420e
Device Description
OnPoint™ Plus Curette, DE, Langer 3-4
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMS | Curette, Periodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41660 | Periodontal curette | A hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840018674554 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.5 | Inch |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 40 – 60 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 350 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 65 – 75 Degrees Fahrenheit