Identity
- Trade Name
- SONICflex 2003 L (Set) FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Model / Reference
- 1.000.8333 FDA UDI
Identifiers
- Catalog Number
- 2003 L Set FDA UDI
- Primary DI / UDI-DI
- EKAV100083330 FDA UDI
- 510(k) Number
- K080089 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system 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
No
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: Ultrasonic dental scaling/debridement system
SONICflex 2003 L (Set) by KaVo Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080089 also covers:
- PiezoLED — KaVo Dental GmbH
- SONICflex 2008 — KaVo Dental GmbH
- SONICflex 2008 L (Set) — KaVo Dental GmbH
- SONICflex 2008 L (Set) — KaVo Dental GmbH
- SONICflex 2008 LS — KaVo Dental GmbH
- SONICflex 2008 S — KaVo Dental GmbH
- SONICflex bevel Tip No. 59 — KaVo Dental GmbH
- SONICflex bevel Tip No. 59 (A) — KaVo Dental GmbH
- SONICflex bevel Tipset (A) — KaVo Dental GmbH
- SONICflex cari-ex 0.8 No. 42 — KaVo Dental GmbH
- SONICflex cari-ex 0.8 No. 42 (A) — KaVo Dental GmbH
- SONICflex cari-ex 1.0 No. 71 (A) — KaVo Dental GmbH
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
- KaVo Dental GmbH
Sources (1)
- FDA UDI 8212a1b6-ff5a-409f-a75f-8216d6b7d820 36 fields · synced May 30, 2026