Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Rubber dam punch FDA UDI
- Device Name
- A hand-held dental instrument used to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. The handles are squeezed together and the plunger (punch) creates a hole in the rubber dam material. It is typically designed to create various hole sizes. This is a reusable device. FDA UDI
- Model / Reference
- RDPN1 FDA UDI
- Description
- A hand-held dental instrument used to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. The handles are squeezed together and the plunger (punch) creates a hole in the rubber dam material. It is typically designed to create various hole sizes. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075612854 FDA UDI
- FDA Product Code
- EME FDA UDI
- GMDN Term
- Rubber dam punch FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rubber dam punch
Osung Mnd by Osung Mnd Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rubber dam punch.
- Premier Rubber Dam Punch — PREMIER DENTAL PRODUCTS COMPANY · Class I
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- American Medicals — AMERICAN MEDICALS · Class I
- Dam Punch 1PK — SMART DENTURE CONVERSIONS, LLC · Class I
- American Medicals — AMERICAN MEDICALS · Class I
- Pomee — POMEE CORPORATION · Class I
- HYGENIC — Coltene/Whaledent Inc. · Class I
- Pomee — POMEE CORPORATION · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Osung Mnd Co., Ltd.
Sources (1)
- FDA UDI b25f428a-d03e-459f-b50d-5254e991d6d8 33 fields · synced Jun 6, 2026