FDA UDI
In Commercial Distribution
🇺🇸 United States
Patterson®
DI: D6620709785022
·
Model: 70978502
·
PATTERSON DENTAL SUPPLY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
300
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Basic Information
- Brand Name
- Patterson®
- Primary DI
- D6620709785022
- Version / Model
- 70978502
- Catalog Number
- 70978502
- Company Name
- PATTERSON DENTAL SUPPLY, INC.
- Labeler DUNS
- 171843584
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 300
- Record Status
- Published
- Publish Date
- 2024-05-08
- Public Version
- 2
- Public Version Date
- 2024-09-09
- Public Version Status
- Update
- Public Device Record Key
- 91ab6954-95dd-4356-b69f-7836a7e66f66
Device Description
DENTAL HANDPIECE AND ACCESSORY
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 45501 | Root canal irrigation handpiece | A hand-operated, air-powered, dental instrument used for the irrigation of prepared root canals to provide thorough debridement of the canal space. It is connected to an air supply via a pressure hose to activate its internal pump mechanism which injects a root canal cleanser via a thin disposable needle into the canal space. This device replaces time consuming manual syringe irrigation and is used for the elimination of pulpal tissue, necrotic materials, and bacteria from the instrumented root canal. 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 | D6620709785020 | HIBCC | ||||
| Primary | D6620709785022 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963664 | 000 |