Identity
- Trade Name
- HeatSync FDA UDI
- Generic Name
- Dental material heater FDA UDI
- Device Name
- Warmer for composite used in dental restorations. FDA UDI
- Model / Reference
- Mini FDA UDI
- Description
- Warmer for composite used in dental restorations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9494170131 FDA UDI
- GMDN Term
- Dental material heater FDA UDI
Classification
- 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
High-level Disinfectant FDA UDI
Category: Dental material heater
HeatSync by Bioclear Matrix Systems, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental material heater.
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- EASE-IT — Rønvig Dental Manufacturing A/S · Class I
- Vista 220V 12cc Syringe Warmer — Vista Dental · Class I
- Phasor Kit — Vista Dental · Class I
- Solventum™ Filtek™ — TOP-Service für Lingualtechnik GmbH · Class I
- Vista 240V 6cc Syringe Warmer — Vista Dental · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Bioclear Matrix Systems, LLC
Sources (1)
- FDA UDI e0be6c98-9144-45bc-95f0-791c32e228b5 33 fields · synced May 30, 2026