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Zirtooth
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Zirtooth H S-4019-H510(k) K102305
by Hass Corp.
Identity
- Device Name
- Zirtooth EUDAMED
- Model / Reference
- Zirtooth H S-4019-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800251000000 EUDAMED
- Basic UDI-DI
- 88000571TD701F2 EUDAMED
- 510(k) Number
- K102305 FDA 510(k)
- FDA Product Code
- EIH FDA 510(k)
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6660 FDA 510(k)
- Regulation Number
- 872.6660 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Zirtooth by Hass Corp. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102305 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000571TD701F2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hass Corp.
- EUDAMED SRN
- KR-MF-000011621
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED e37de29b-0d66-40d7-8ce0-df338dce6955 61 fields · synced Jul 11, 2026
- FDA 510(k) K102305 24 fields · synced May 18, 2026