FDA UDI
In Commercial Distribution
🇺🇸 United States
STEEL ABRASIVE STRIPS, 4 mm, double side coated, fine grits
DI: J01046121
·
Model: 46121
·
Produits dentaires S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- STEEL ABRASIVE STRIPS, 4 mm, double side coated, fine grits
- Primary DI
- J01046121
- Version / Model
- 46121
- Company Name
- Produits dentaires S.A.
- Labeler DUNS
- 480420090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-29
- Public Version
- 1
- Public Version Date
- 2022-07-07
- Public Version Status
- New
- Public Device Record Key
- b66ed875-054c-41a8-8ba4-e051b48c4fe9
Device Description
Abrasive strips are used during restorative treatments to adjust / shape / smooth / reduce the interproximal area & contact points of the tooth‘s crown (artificial or natural). The abrasive strips are made of stainless-steel base coated with abrasive grit (corundum or diamond). The products are used in the dentistry field. Pack of 12 pcs
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
- Yes
- 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 |
|---|---|---|---|---|
| EHM | Strip, Polishing Agent | Dental | 872.6010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35702 | Dental abrasive strip, single-use | A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J01046121 | HIBCC |
Customer Contacts
- Phone
- +41219212631
- [email protected]