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KSK Dental Dam (cut) 6"x 6" Non-Latex
EUDAMEDFDA UDIClass I (EU MDR)
Ref 01023040
Identity
- Trade Name
- KSK Dental Dam (cut) 6"x 6" Non-Latex EUDAMEDDENTECH FDA UDI
- Generic Name
- Rubber dam, non-latex FDA UDI
- Device Name
- Rubber Dam isolation technique related products EUDAMEDKSK Dental Dam Medium (cut) 6" x 6" Non-Latex, set of 20 sheets FDA UDI
- Model / Reference
- 01023040 EUDAMEDFDA UDI
- Description
- KSK Dental Dam Medium (cut) 6" x 6" Non-Latex, set of 20 sheets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560218661661 EUDAMEDFDA UDI
- Basic UDI-DI
- 456021866dentech1571201QD EUDAMED
- FDA Product Code
- EIE FDA UDI
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
- GMDN Term
- Rubber dam, non-latex FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
KSK Dental Dam (cut) 6"x 6" Non-Latex by Dentech Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 456021866dentech1571201QD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dentech Corporation
- EUDAMED SRN
- JP-MF-000046690
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 27797807-1367-4a9c-a34c-5e90ac0985d8 61 fields · synced Jun 18, 2026
- FDA UDI 4fc38520-047f-477e-92ed-c81d895bc0c6 33 fields · synced May 30, 2026