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CleaniCal
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 00017510(k) K201799
by Maruchi
Identity
- Trade Name
- CleaniCal FDA UDI
- Generic Name
- Endodontic temporary cement FDA UDI
- Device Name
- CleaniCal EUDAMED1. Description: CleaniCal is a type of pre-filled syringe of Calcium Hydroxide Paste with a pH above 12.3. It is applied obturation and intracanal dressings of the root canal following removal of infected or necrotic pulp. It does not replace instrumentation / antibiotics to treat infected canals. 2. Principle of operation: As a prefilled syringe product to quickly and easily dispense calcium hydroxide paste into the root canal, the CleaniCal consists of calcium hydroxide having disinfection effect. It is non-aqueous solvent to be easily dispensed in the root canal as a paste type product, and viscosity agent. 3. Storage conditions: 1) The product must be stored at room temperature avoiding high temperature and humidity. 2) The used 24 gauge tip shall be kept after its metal part cut off. A new 24 gauge tip must be used in next use. 4. Shelf life: 2 years from date of manufacture. FDA UDI
- Model / Reference
- 00017 EUDAMEDCleaniCal FDA UDI
- Description
- 1. Description: CleaniCal is a type of pre-filled syringe of Calcium Hydroxide Paste with a pH above 12.3. It is applied obturation and intracanal dressings of the root canal following removal of infected or necrotic pulp. It does not replace instrumentation / antibiotics to treat infected canals. 2. Principle of operation: As a prefilled syringe product to quickly and easily dispense calcium hydroxide paste into the root canal, the CleaniCal consists of calcium hydroxide having disinfection effect. It is non-aqueous solvent to be easily dispensed in the root canal as a paste type product, and viscosity agent. 3. Storage conditions: 1) The product must be stored at room temperature avoiding high temperature and humidity. 2) The used 24 gauge tip shall be kept after its metal part cut off. A new 24 gauge tip must be used in next use. 4. Shelf life: 2 years from date of manufacture. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800071200017 EUDAMEDFDA UDI
- Basic UDI-DI
- 8800071200017UJ EUDAMED
- 510(k) Number
- K201799 FDA UDI
- FDA Product Code
- KIF FDA UDIEJK FDA UDI
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
- GMDN Term
- Endodontic temporary cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3820 FDA UDI872.3250 FDA UDI
- Market of Registration
- Hungary EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental coating, tooth-desensitizing
CleaniCal by Maruchi — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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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 | K201799 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8800071200017UJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Maruchi
- EUDAMED SRN
- KR-MF-000030192
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED 5c2bced4-5780-4149-8257-89e440d7d4bd 85 fields · synced Jun 18, 2026
- FDA UDI 2ef4a0a0-3a51-4d6a-b4ee-a639e1c7b619 35 fields · synced May 30, 2026
- FDA 510(k) K201799 1 fields · synced May 18, 2026