Identity
- Trade Name
- StarDental Instrument Solutions FDA UDI
- Generic Name
- Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable FDA UDI
- Device Name
- TITAN SCALER TIP - SICKLE FDA UDI
- Model / Reference
- 261667 FDA UDI
- Description
- TITAN SCALER TIP - SICKLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- D7022616670 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 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: Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable
StarDental Instrument Solutions by Dentalez, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable.
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- KOMET Dental Diamond Instruments — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Dental Diamond Instruments — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Dental Diamond Instruments — Gebr. Brasseler GmbH & Co. KG · Class I
- Varios/VarioSurg/Ti-Max — NAKANISHI INC. · Class II
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
- Dentalez, Inc.
Sources (1)
- FDA UDI 9915a292-2ce2-4321-839a-95de00ed5ec9 34 fields · synced May 30, 2026