Identity
- Trade Name
- Patterson® FDA UDI
- Generic Name
- Root canal irrigation handpiece FDA UDI
- Device Name
- DENTAL HANDPIECE AND ACCESSORY FDA UDI
- Model / Reference
- 70978502 FDA UDI
- Description
- DENTAL HANDPIECE AND ACCESSORY FDA UDI
Identifiers
- Catalog Number
- 70978502 FDA UDI
- Primary DI / UDI-DI
- D6620709785022 FDA UDI
- 510(k) Number
- K963664 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Root canal irrigation handpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Root canal irrigation handpiece
Patterson® by Patterson Dental Supply, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K963664 also covers:
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- SCHICK — SIRONA DENTAL, INC.
- SCHICK — SIRONA DENTAL, INC.
- SCHICK — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- SCHICK ELITE — SIRONA DENTAL, INC.
- XIOS — SIRONA DENTAL, INC.
- XIOS — SIRONA DENTAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Patterson Dental Supply, Inc.
Sources (1)
- FDA UDI 91ab6954-95dd-4356-b69f-7836a7e66f66 35 fields · synced May 30, 2026