Harvest Dental Polymer Blocks (ZCAD, Aurora)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132937 FDA 510(k)
- FDA Product Code
- EBG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3770 FDA 510(k)
- Regulation Number
- 872.3770 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Harvest Dental Polymer Blocks (ZCAD, Aurora) are PMMA (polymethyl methacrylate) blanks designed for use with CAD/CAM milling systems. The device serves as the material for manufacturing temporary crowns and bridges.
The device is supplied as a polymer block for use in dental laboratories or clinical settings with CAD/CAM systems. It is intended for single-use in the fabrication of temporary dental restorations and is regulated under FDA 510(k) clearance K132937 with product code EBG.
Frequently asked questions
What is the intended use of Harvest Dental Polymer Blocks (ZCAD, Aurora)?
These blocks are designed as PMMA material for use with CAD/CAM milling systems to fabricate temporary crowns and bridges in dental laboratories or clinical settings.
How is the Harvest Dental Polymer Block supplied and is it reusable?
The device is supplied as a solid polymer block intended for single-use only in the milling process to create temporary dental restorations, after which it is discarded.
What material are Harvest Dental Polymer Blocks (ZCAD, Aurora) made from?
The blocks are made of polymethyl methacrylate (PMMA), a dental-grade polymer suitable for milling temporary restorations using CAD/CAM technology.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) (K132937) — FDA 510 (k ..., PDF HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) 510 (k)… - FDA.report, Harvest Dental Polymer Blocks (zcad, Aurora) 510 (k) FDA Premarket ..., fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132937 | Class II | Active |
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Manufacturer
- Manufacturer
- Harvest Dental Products, LLC
Sources (1)
- FDA 510(k) K132937 24 fields · synced Sep 22, 2026