Identity
- Trade Name
- BENCO FDA UDI
- Generic Name
- Dental burnisher FDA UDI
- Device Name
- Calcium hydroxide placement instrument 5.5" SE FDA UDI
- Model / Reference
- 5094-579 FDA UDI
- Description
- Calcium hydroxide placement instrument 5.5" SE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00366975005267 FDA UDI
- FDA Product Code
- GDZ FDA UDI
- GMDN Term
- Dental burnisher FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental burnisher
Benco by Benco Dental Supply Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental burnisher.
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · 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 |
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Manufacturer
- Manufacturer
- Benco Dental Supply Co.
Sources (1)
- FDA UDI b15c8188-f5fe-4f83-b39e-0afd6a24bf97 34 fields · synced May 31, 2026