FDA UDI
In Commercial Distribution
🇺🇸 United States
DCI Edge
DI: 00810021439488
·
Model: PJT661
·
DCI International, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DCI Edge
- Primary DI
- 00810021439488
- Version / Model
- PJT661
- Company Name
- DCI International, LLC
- Labeler DUNS
- 032221423
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-13
- Public Version
- 1
- Public Version Date
- 2026-04-21
- Public Version Status
- New
- Public Device Record Key
- 5964180d-a53c-472b-9ebc-57b5c848c619
Device Description
3 NSK Air, High Speed, Z990KL w/1 (Kavo Type) Coupler Bundle w/DCI Edge
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66244 | Dental surgical power tool motorized handpiece/set, pneumatic | A pneumatically-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 a pneumatic motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces, and typically includes a pneumatic hose; 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 |
|---|---|---|---|---|---|---|
| Primary | 00810021439488 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230888 | 000 |