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Ultradent
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DENTALAUPIBLU02300636Model Dental Dam
Identity
- Trade Name
- DermaDam Latex Heavy - 36pk EUDAMEDUltradent FDA UDI
- Generic Name
- Rubber dam, Hevea-latex FDA UDI
- Device Name
- DermaDam Latex Heavy - 36pk FDA UDI
- Model / Reference
- Dental Dam EUDAMEDDENTALAUPIBLU02300636 EUDAMEDHeavy FDA UDI
- Description
- DermaDam Latex Heavy - 36pk FDA UDI
Identifiers
- Catalog Number
- DENTALAUPIBLU02300636 FDA UDI
- Primary DI / UDI-DI
- 05060748681942 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060748684DLADD2D EUDAMED
- FDA Product Code
- EIE FDA UDI
- EMDN Code
- Y0504 ARMS, TORSO AND LEGS RE-EDUCATION DEVICES EUDAMED
- GMDN Term
- Rubber dam, Hevea-latex FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Market of Registration
- Ireland 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
Yes
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
Yes
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
Yes
FDA UDI
Category: Rubber dam, Hevea-latex
Ultradent by Four D Rubber Company Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rubber dam, Hevea-latex.
- ISOTEX Band - Blueberry - 0.30mm - 1.5M - Latex Dispenser — Four D Rubber Company Ltd · Class I
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- TheraBand Exercise Band 2.5m Yellow in Zipper Bag with Retail Carton - EU — The Hygenic Company, LLC · Class I
- BANCO DE COLSON (2 PLAZAS) — ORTOTECSA,S.L. · Class I
- Non-Latex .18/.23mm Medium Royal Blue 6”x 6“ 15pcs — Four D Rubber Company Ltd · Class I
- LATEX FREE .23/.28mm Heavy - D. Blue 6" x 6" 20pcs — Four D Rubber Company Ltd · Class I
- Theraband 25 Yard Non-Latex Black CE Mark — The Hygenic Company, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Four D Rubber Company Limited
Sources (2)
- FDA UDI 7f651b50-346d-47a8-90bf-56190ab8e1f1 35 fields · synced Jun 18, 2026
- EUDAMED fe82776f-05c8-4086-9af5-3454bb63fa1c 61 fields · synced Jun 18, 2026