ScanX Barrier Envelopes
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ScanX Barrier Envelopes FDA UDI
- Generic Name
- Digital imaging cassette/storage phosphor screen, dental FDA UDI
- Device Name
- ScanX Barrier Envelope EUDAMEDAn envelope that provides a barrier against fluid to protect PSP plates used for X-ray images. They also prevent cross contamination between patients. FDA UDI
- Model / Reference
- G8511-1 EUDAMEDFDA UDIG8511-0 EUDAMEDFDA UDIG8511-2 EUDAMEDFDA UDI73248-2K EUDAMEDFDA UDI
- Description
- An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images. They also prevent cross contamination between patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- +D678G851111 EUDAMED+D678732482K2 EUDAMED+D678G851121 EUDAMED+D678G851101 EUDAMEDD678G851111 FDA UDID678G851101 FDA UDID678G851121 FDA UDID678732482K1 FDA UDI
- Basic UDI-DI
- ++D678G85111JR EUDAMED++D678732482K24 EUDAMED++D678G85112JT EUDAMED++D678G85110JP EUDAMED
- Unit of Use DI
- +D678G851110 EUDAMED+D678732482K0 EUDAMED+D678G851120 EUDAMED+D678G851100 EUDAMED
- 510(k) Number
- FDA Product Code
- PEM FDA 510(k)FDA UDI
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Digital imaging cassette/storage phosphor screen, dental FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4370 FDA 510(k)
- Regulation Number
- 878.4370 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The ScanX Barrier Envelopes are classified as Dental Barriers and Sleeves, designed to protect intraoral phosphor storage plates (PSPs) during use. These sterile, single-use envelopes create a barrier to prevent cross-contamination and infection, ensuring hygienic handling of digital sensors in dental imaging procedures.
Supplied in sizes 0, 1, and 2, these envelopes are intended for single-use and feature an easy-open design to minimize contamination risk. They are regulated under FDA 510K clearance and MDR compliance, with a device classification of Class II. Storage requires adherence to standard sterile packaging protocols, and no MRI safety considerations apply.
Frequently asked questions
What are the ScanX Barrier Envelopes designed to protect, and why is this protection important in dental imaging?
The ScanX Barrier Envelopes are specifically designed to protect intraoral phosphor storage plates (PSPs) used in digital dental imaging. This protection is critical because the envelopes create a sterile barrier that prevents cross-contamination and infection during handling, ensuring hygienic use of the sensors in dental procedures. This helps maintain patient safety and procedural integrity.
Are the ScanX Barrier Envelopes reusable, and if not, what makes them suitable for single-use?
No, the ScanX Barrier Envelopes are intended for single-use only. Their design—including the sterile packaging and easy-open feature—minimizes contamination risk during use, making them ideal for one-time application. Reusing them could compromise sterility and patient safety, which is why they are explicitly labeled for single-use.
What sizes are available for the ScanX Barrier Envelopes, and how does this relate to the PSPs they protect?
The ScanX Barrier Envelopes come in three sizes: 0, 1, and 2. These sizes correspond to the dimensions of intraoral phosphor storage plates (PSPs) commonly used in dental imaging, ensuring a proper fit and effective barrier protection for each sensor type. The sizing helps clinicians select the correct envelope for their specific PSP.
How should the ScanX Barrier Envelopes be stored, and are there any special considerations for maintaining their sterility?
The ScanX Barrier Envelopes should be stored according to standard sterile packaging protocols, as they are supplied in sterile condition. This means keeping them in their original, unopened packaging until ready for use and avoiding exposure to moisture, heat, or physical damage that could compromise sterility. Proper storage ensures the envelopes remain effective in preventing contamination during dental procedures.
Are there any safety concerns related to using the ScanX Barrier Envelopes in medical imaging environments, such as MRI compatibility?
No MRI safety considerations apply to the ScanX Barrier Envelopes, as they are made of materials that do not interfere with magnetic resonance imaging. This makes them suitable for use in environments where both dental imaging and MRI procedures may occur, without posing risks to patients or equipment.
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: ScanX Barrier Envelopes - Air Techniques, ScanX Barrier Envelopes - Air Techniques, Air Techniques ScanX Barrier Envelopes | Supply Doc, Air Techniques ScanX Barrier Envelopes - amtouch.com, ScanX™ Barrier Envelopes | Henry Schein Dental
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190949 | Class II | Active |
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Manufacturer
- Manufacturer
- Air Techniques, Inc.
Sources (9)
- FDA 510(k) K190949 24 fields · synced Sep 18, 2026
- FDA UDI 6c359f9b-c4ea-4f82-8f01-4eb3e139a8d5 34 fields · synced May 29, 2026
- FDA UDI 20043016-c746-4a22-8f3b-0b6844def4d6 34 fields · synced May 30, 2026
- FDA UDI 1c9b6fad-193d-4213-9e56-a6aa15b40122 34 fields · synced May 30, 2026
- FDA UDI 796345a1-b68b-4bb4-b423-a373bd35d556 35 fields · synced May 30, 2026
- EUDAMED 3e7e3933-974d-4556-8ae6-eb7e629cfa50 61 fields · synced Jul 9, 2026
- EUDAMED 702eacb1-d174-4281-a595-db71aeffd617 61 fields · synced Jul 20, 2026
- EUDAMED b1d1309a-4c97-4ae7-83aa-23ea4b9b4066 61 fields · synced Jul 21, 2026
- EUDAMED 0a0a8567-73f3-4a2c-9bb1-038e3dc48cc3 61 fields · synced Jul 28, 2026