FDA UDI
In Commercial Distribution
🇺🇸 United States
EdgeApex HP™
DI: 00818365029013
·
Model: EAPEXLH
·
US ENDODONTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- EdgeApex HP™
- Primary DI
- 00818365029013
- Version / Model
- EAPEXLH
- Catalog Number
- EAPEXLH
- Company Name
- US ENDODONTICS, LLC
- Labeler DUNS
- 061317427
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2023-06-25
- Public Version
- 1
- Public Version Date
- 2023-07-03
- Public Version Status
- New
- Public Device Record Key
- 05c7d85d-d648-4b7a-9aaa-be915e005385
Device Description
EdgeApex HP Lip Hook (5 pack)
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| EKX | Handpiece, direct drive, ac-powered | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66245 | Dental surgical power tool motorized handpiece/set, electric | An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10818365029010 | GS1 | ||||
| Primary | 00818365029013 | GS1 |
Customer Contacts
- Phone
- +1(423)283-0047 ext. 103
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203320 | 000 |