Identity
- Trade Name
- KSK Rubber Dam Punch EUDAMEDDENTECH FDA UDI
- Generic Name
- Rubber dam punch FDA UDI
- Device Name
- Rubber Dam isolation technique related products EUDAMED
- Model / Reference
- 01021011 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560218661197 EUDAMEDFDA UDI
- Basic UDI-DI
- 456021866dentech1571201QD EUDAMED
- Direct Marketing DI
- 04560218661197 EUDAMED
- FDA Product Code
- EJG FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Rubber dam punch FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
KSK Rubber Dam Punch 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 ef7cb3e8-28f2-45d6-8e99-153dfef61c8d 61 fields · synced Jun 18, 2026
- FDA UDI 0403c578-a079-45f7-b551-9d8653cc619b 32 fields · synced May 29, 2026