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Sign in to claim this brandEDELWEISS DR ag
US
Last updated May 23, 2026
What EDELWEISS DR ag makes
Edelweiss DR ag manufactures custom-made dental composite resin kits designed for dental restorations and aesthetic applications. Their product line includes a range of composite resins for body, flowable body, and shade-specific applications, such as skin tones and translucent formulations, as well as introductory starter kits for dental professionals.
The company’s devices fall under FDA Class II regulation and are listed in the FDA’s Unique Device Identifier (UDI) database. Edelweiss DR ag operates from the United States, adhering to applicable U.S. medical device compliance requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Edelweiss DR ag manufacture?
Edelweiss DR ag specializes in custom-made dental composite resin kits. These are primarily used for dental restorations and cosmetic applications, such as filling cavities, repairing teeth, or enhancing dental aesthetics. The company’s products include composite resins for general body restorations, flowable body formulations (for easier application), and specialized shades like skin tones and translucent variants. These materials are designed to blend seamlessly with natural teeth.
Where is Edelweiss DR ag based, and does that affect its regulatory compliance?
Edelweiss DR ag is based in the United States. Since the company operates within the U.S., its devices must comply with U.S. medical device regulations, including those set by the FDA. The regulatory framework ensures that dental composite resins—classified as Class II devices—meet safety, performance, and labeling requirements before they are marketed. Compliance involves adhering to FDA guidelines for manufacturing, testing, and post-market surveillance.
Which regulatory registries or databases list Edelweiss DR ag’s devices?
Edelweiss DR ag’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling better tracking, traceability, and transparency in the medical device supply chain. Listing in the UDI database helps healthcare providers, regulators, and other stakeholders verify the identity and regulatory status of the company’s dental composite resin kits.
How are Edelweiss DR ag’s dental composite resin kits classified by regulators?
Edelweiss DR ag’s dental composite resin kits are classified as FDA Class II devices. This classification is determined based on the level of risk associated with the product. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or labeling requirements to mitigate potential risks, such as allergic reactions or improper application.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 486793370
Catalogue (51)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| inspiro Body i1 | 3410 | FDA UDI | Class II | Active |
| inspiro Flowable Body i6 | 3660 | FDA UDI | Class II | Active |
| inspiro Skin White | 3310 | FDA UDI | Class II | Active |
| inspiro Skin Transparent | 3530 | FDA UDI | Class II | Active |
| inspiro Effect Shade Azur | 3800 | FDA UDI | Class II | Active |
| inspiro Body i3 | 3430 | FDA UDI | Class II | Active |
| inspiro Body i5 | 3250 | FDA UDI | Class II | Active |
| inspiro Body i2 | 3225 | FDA UDI | Class II | Active |
| inspiro Body i0 | 3400 | FDA UDI | Class II | Active |
| inspiro Intro Kit Compule | 3030 | FDA UDI | Class II | Active |
| inspiro Body i1 | 3215 | FDA UDI | Class II | Active |
| inspiro Flowable Body i4 | 3640 | FDA UDI | Class II | Active |
| inspiro Mini Kit General | 3055 | FDA UDI | Class II | Active |
| inspiro Body i1 | 3210 | FDA UDI | Class II | Active |
| inspiro Body i4 | 3245 | FDA UDI | Class II | Active |
| inspiro Body i4 | 3240 | FDA UDI | Class II | Active |
| inspiro Flowable Body i5 | 3650 | FDA UDI | Class II | Active |
| inspiro Flowable Body i2 | 3620 | FDA UDI | Class II | Active |
| inspiro Skin White | 3315 | FDA UDI | Class II | Active |
| inspiro Skin Bleach | 3300 | FDA UDI | Class II | Active |
| inspiro Body i3 | 3235 | FDA UDI | Class II | Active |
| inspiro Body i0 | 3200 | FDA UDI | Class II | Active |
| inspiro Skin Ivory | 3340 | FDA UDI | Class II | Active |
| inspiro Body i4 | 3440 | FDA UDI | Class II | Active |
| inspiro Effect Shade White Opaque | 3820 | FDA UDI | Class II | Active |
| inspiro Effect Shade Ice | 3810 | FDA UDI | Class II | Active |
| inspiro Flowable Skin Neutral | 3720 | FDA UDI | Class II | Active |
| inspiro Body i2 | 3220 | FDA UDI | Class II | Active |
| inspiro Effect Shade Chroma | 3830 | FDA UDI | Class II | Active |
| inspiro Skin Bleach | 3500 | FDA UDI | Class II | Active |
| inspiro Master Kit Compule | 3010 | FDA UDI | Class II | Active |
| inspiro Skin Bleach | 3305 | FDA UDI | Class II | Active |
| inspiro Flowable Body i1 | 3610 | FDA UDI | Class II | Active |
| inspiro Skin White | 3510 | FDA UDI | Class II | Active |
| inspiro Compule Trial Kit | 3070 | FDA UDI | Class II | Active |
| inspiro Flowable Body i3 | 3630 | FDA UDI | Class II | Active |
| inspiro Body i3 | 3230 | FDA UDI | Class II | Active |
| inspiro Flowable Skin White | 3710 | FDA UDI | Class II | Active |
| inspiro Mini Kit Esthetic Anterior | 3050 | FDA UDI | N/A | Active |
| inspiro Skin Neutral | 3325 | FDA UDI | Class II | Active |
| inspiro Flowable Body i7 | 3670 | FDA UDI | Class II | Active |
| inspiro Skin Neutral | 3520 | FDA UDI | Class II | Active |
| inspiro Body i2 | 3420 | FDA UDI | Class II | Active |
| inspiro Skin Transparent | 3330 | FDA UDI | Class II | Active |
| inspiro Body i5 | 3440 | FDA UDI | Class II | Active |
| inspiro Master Kit Syringe | 3020 | FDA UDI | Class II | Active |
| inspiro Skin Ivory | 3540 | FDA UDI | Class II | Active |
| inspiro Skin Neutral | 3320 | FDA UDI | Class II | Active |
| inspiro Effect Shade Dark Brown | 3840 | FDA UDI | Class II | Active |
| inspiro Flowable Skin Bleach | 3700 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Edelweissdr Ag Zug · CH FEI 3011148229