Identity
- Trade Name
- SCALER D/E RULE 3-4 HF HANDLE FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Model / Reference
- 70-4254HF FDA UDI
Identifiers
- Primary DI / UDI-DI
- D928704254HF0 FDA UDI
- FDA Product Code
- EMN FDA UDI
- GMDN Term
- Manual dental scaler, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual dental scaler, reusable
Scaler D/E Rule 3-4 Hf Handle by W.H. Holden, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual dental scaler, reusable.
- A. Titan Instruments — A.Titan Instruments · Class I
- J & J INSTRUMENTS — J&J Instruments, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- DHP Scaler Instruments — Dental Health Products Inc · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
- Pomee — POMEE CORPORATION · Class I
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
- W.H. Holden, Inc.
Sources (1)
- FDA UDI 0bd4d64f-cca7-4e24-b1cb-97485a27a52a 32 fields · synced May 30, 2026