Identity
- Trade Name
- JMU FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- JMU Dental Impression Materials, Putty-Fast Set, 400g Base + 400g Catalyst and 2 Measuring Spoons FDA UDI
- Model / Reference
- 31501002 FDA UDI
- Description
- JMU Dental Impression Materials, Putty-Fast Set, 400g Base + 400g Catalyst and 2 Measuring Spoons FDA UDI
Identifiers
- Primary DI / UDI-DI
- D930315010020 FDA UDI
- 510(k) Number
- K133071 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Silicone dental impression material
Jmu by Jmu Dental, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
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- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Cleared under the same submission
K133071 also covers:
- Nobilium — CMP INDUSTRIES LLC
- JMU — JMU DENTAL, INC
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
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 II | Pending data |
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Manufacturer
- Manufacturer
- Jmu Dental, Inc
Sources (1)
- FDA UDI e5dd3291-56eb-4037-8cef-de953a8a97fc 34 fields · synced Jun 8, 2026