Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Dental articulator FDA UDI
- Device Name
- A hinged, mechanical, dental device designed to simulate the movement of a patient's upper and lower jaws and onto which maxillary and mandibular casts or models are attached according to a pre-recorded intermaxillary relationship. It is designed to simulate all or part of the mandibular movements and is used for, e.g., examination, diagnosis, or to construct dental appliances. This is a reusable device. FDA UDI
- Model / Reference
- ACBA1 FDA UDI
- Description
- A hinged, mechanical, dental device designed to simulate the movement of a patient's upper and lower jaws and onto which maxillary and mandibular casts or models are attached according to a pre-recorded intermaxillary relationship. It is designed to simulate all or part of the mandibular movements and is used for, e.g., examination, diagnosis, or to construct dental appliances. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075601490 FDA UDI
- FDA Product Code
- EJP FDA UDI
- GMDN Term
- Dental articulator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3150 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: Dental articulator
Osung Mnd by Osung Mnd Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental articulator.
- Bite fork — Candulor AG · Class I
- W.O.W.™ — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Denar Mark 330 Articulator — WHIP-MIX CORP. · Class I
- HANDY IIM — SHOFU DENTAL CORP. · Class I
- Stratos 300 Grundausstattung — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class I
- TrollFoil — Directa AB · Class I
- MA2340 W/STRAPS — WHIP-MIX CORP. · Class I
- Hanau Wide-Vue Articulator — WHIP-MIX CORP. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Osung Mnd Co., Ltd.
Sources (1)
- FDA UDI 6ccd068a-404e-4087-97cd-ace2707ee3d8 33 fields · synced Jun 1, 2026