gudid
Primary ID: 540010
DeltaFil (UDI 540010)
Manufactured by DMG Chemisch-Pharmazeutische Fabrik GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DeltaFil - Primary ID 540010
Device Regulatory Overview
The DeltaFil (Model/Catalog Number: 540010) is a medical device manufactured by DMG Chemisch-Pharmazeutische Fabrik GmbH. This product is indexed under FDA Product Code / Category Classification EMA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 540010
- Product Code / EMDN
- EMA
- Device Name
- DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFilchemically bonds to enamel and dentine and releases fluoride ions. It is available in the shadesA1, A2, A3 and A4 based on the Vita color system and White and Dark. Each capsule contains a minimumusable amount of 0.13 ml.DeltaFil Conditioner is an aqueous polyacrylic acid solution for treating the smear layerfollowing preparation and for conditioning the cavity, which optimizes the bonding of DeltaFilto the tooths structure.DeltaFilSample Pack: 5 Applicap @ 370 mg powder, 75 mg liquid (0.07 ml) (3x Shade A2, 1x White, 1x Dark),DeltaFil Conditioner 1 Bottle @ 2 g
- Database Sync Date
- 2026-08-09 09:23:50
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of DeltaFil?
The registered manufacturer of record for DeltaFil is DMG Chemisch-Pharmazeutische Fabrik GmbH.
What is the Primary UDI-DI identifier for DeltaFil?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 540010.
What classification code is assigned to this device?
This device is registered under product classification code EMA.
Similar Classification Devices (EMA)
Other Devices by DMG Chemisch-Pharmazeutische Fabrik GmbH
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