Identity
- Trade Name
- Spoon Tip FDA UDI
- Generic Name
- Endodontic filling material condenser FDA UDI
- Device Name
- Spoon Tip FDA UDI
- Model / Reference
- 973-0218 FDA UDI
- Description
- Spoon Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989069587 FDA UDI
- FDA Product Code
- EAT FDA UDI
- GMDN Term
- Endodontic filling material condenser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1720 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endodontic filling material condenser
Spoon Tip by Ormco Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic filling material condenser.
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- HU-FRIEDY — HU-FRIEDY MFG CO., LLC · Class I
- KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
Sources (1)
- FDA UDI 96cd5d55-dcd4-49ef-b3e2-d2848f2108d1 34 fields · synced Jun 9, 2026