FDA UDI
In Commercial Distribution
🇺🇸 United States
EdgeSequel Sapphire
DI: 07640452462129
·
Model: ES04153025ASST
·
FKG Dentaire Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
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Basic Information
- Brand Name
- EdgeSequel Sapphire
- Primary DI
- 07640452462129
- Version / Model
- ES04153025ASST
- Catalog Number
- ES04153025ASST
- Company Name
- FKG Dentaire Sàrl
- Labeler DUNS
- 482884061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2025-11-28
- Public Version
- 1
- Public Version Date
- 2025-12-08
- Public Version Status
- New
- Public Device Record Key
- d9b3d870-f2fa-459e-b604-5e01ac25c79a
Device Description
EdgeSequel Sapphire .04 Assortment – 015/020/025/030 – 25mm
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKS | File, Pulp Canal, Endodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63550 | Rotary/reciprocating endodontic file/rasp, single-use | A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 07640452466134 | GS1 | ||||
| Primary | 07640452462129 | GS1 |