Identity
- Trade Name
- MASTER-DENT FDA UDI
- Generic Name
- Dental impression material syringe, reusable FDA UDI
- Device Name
- Vinyl Polysiloxane Putty, 2 putty jars (300ml Catalyst & 300ml Base) (600 ml total) & 2 scoops FDA UDI
- Model / Reference
- 20-000 FDA UDI
- Description
- Vinyl Polysiloxane Putty, 2 putty jars (300ml Catalyst & 300ml Base) (600 ml total) & 2 scoops FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816526021685 FDA UDI
- 510(k) Number
- K801380 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Dental impression material syringe, reusable 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
Yes
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
No
FDA UDI
Category: Dental impression material syringe, reusable
Master-Dent by Dentonics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression material syringe, reusable.
- Plasdent — PLASDENT CORP. · Class I
- Plasdent — PLASDENT CORP. · Class I
- Plasdent — PLASDENT CORP. · Class I
- Astek — Young Innovations, Inc. · Class I
- COE SYRINGE — Gc America Inc. · Class I
- Astek — Young Innovations, Inc. · Class I
- easy2 impression syringe pink — DETAX GmbH · Class I
- Astek — Young Innovations, Inc. · Class I
Cleared under the same submission
K801380 also covers:
- MASTER-DENT — DENTONICS, INC.
- Health-Tec VPS Impression Material — Dental Health Products Inc
- Health-Tec VPS Impression Material — Dental Health Products Inc
- Health-Tec VPS Impression Material — Dental Health Products Inc
- Health-Tec VPS Impression Material — Dental Health Products Inc
- Health-Tec VPS Impression Material — Dental Health Products Inc
- Health-Tec VPS Impression Material — Dental Health Products Inc
- Health-Tec VPS Impression Material — Dental Health Products Inc
- Health-Tec VPS Impression Material — Dental Health Products Inc
- IQ Dental — IQ DENTAL SUPPLY LLC
- SmartPractice — SMART HEALTH LLC
- SmartPractice — SMART HEALTH LLC
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
- Dentonics, Inc.
Sources (1)
- FDA UDI 220c4eaf-a9eb-4df4-89a2-2f955b387076 35 fields · synced May 30, 2026