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DiaTemp Flow

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K192022Ref A2003-1101Model DiaTemp BLUERef A2003-2101Model DiaTemp Flow BLUERef A2003-1201Model DiaTemp YELLOW

by Diadent Group International

Identity

Trade Name
DiaTemp Flow EUDAMEDFDA UDI
DiaTemp EUDAMEDFDA UDI
Generic Name
Temporary dental crown/bridge resin FDA UDI
Device Name
DiaTemp EUDAMED
DiaTemp Flow EUDAMED
DiaTemp Flow is a temporary fililng material that sets with curing light. In case that the cavity is not permanently restored, DiaTemp Flow can be used as a temporary restoration until the next appointment. DiaTemp Flow has four models and packaged with the syringe, disposable tip, protective cap. FDA UDI
DiaTemp is a temporary filling material that sets with curing light. In case the cavity is not permanently restored, Diatemp can be used as a temporary restoration until the next appointment. DiaTemp has four models and packaged with syringe and protective cap. FDA UDI
Model / Reference
DiaTemp BLUE EUDAMED
A2003-1101 EUDAMED
DiaTemp Flow BLUE EUDAMED
A2003-2101 EUDAMED
DiaTemp YELLOW EUDAMED
A2003-1201 EUDAMED
Blue 1.8g FDA UDI
Blue 3g FDA UDI
Yellow 3g FDA UDI
Description
DiaTemp Flow is a temporary fililng material that sets with curing light. In case that the cavity is not permanently restored, DiaTemp Flow can be used as a temporary restoration until the next appointment. DiaTemp Flow has four models and packaged with the syringe, disposable tip, protective cap. FDA UDI
DiaTemp is a temporary filling material that sets with curing light. In case the cavity is not permanently restored, Diatemp can be used as a temporary restoration until the next appointment. DiaTemp has four models and packaged with syringe and protective cap. FDA UDI

Identifiers

Catalog Number
A2003-2101 FDA UDI
A2003-1101 FDA UDI
A2003-1201 FDA UDI
Primary DI / UDI-DI
08806383565585 EUDAMEDFDA UDI
08806383565561 EUDAMEDFDA UDI
08806383565578 EUDAMEDFDA UDI
Basic UDI-DI
B-08806383565561 EUDAMED
B-08806383565585 EUDAMED
B-08806383565578 EUDAMED
510(k) Number
K192022 FDA 510(k)FDA UDI
K192158 FDA UDI
FDA Product Code
EBG FDA 510(k)FDA UDI
EMDN Code
Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
GMDN Term
Temporary dental crown/bridge resin FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3770 FDA 510(k)
Regulation Number
872.3770 FDA 510(k)FDA UDI
Market of Registration
Netherlands EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

DiaTemp Flow is a low-viscosity, light-cured flowable composite material classified as a Dental Temporary Restorative Material (Product Code: EBG). It is designed for temporary and intermediate restorations, including inlays, onlays, and relining of crowns and bridges, providing a durable and adaptable solution for prepared cavities.

This material is supplied as a single-component, flowable composite that requires light activation for curing. It is intended for single-use applications in dental settings and is not reusable. The product adheres well to tooth structures, ensuring a tight seal at margins, and can be removed in one piece for ease of application and removal. Authorized under FDA 510(k) clearance (K192022) and MDD compliance, it adheres to dental regulatory standards for temporary restorative materials.

Frequently asked questions

What types of dental restorations is DiaTemp Flow specifically designed for, and how does its flowable nature benefit the procedure?

DiaTemp Flow is designed for temporary and intermediate restorations, including inlays, onlays, and relining of crowns and bridges. Its low-viscosity, flowable composition allows it to adapt easily to prepared cavities, filling gaps and contours precisely. This ensures a tight seal at the margins, reducing the risk of microleakage and providing a durable, long-lasting temporary solution.

Is DiaTemp Flow reusable, or is it intended for single-use only? How does this affect its clinical use?

DiaTemp Flow is explicitly intended for single-use applications in dental settings. This design choice ensures sterility and consistency in performance, as reuse could compromise the material’s integrity, introduce contamination, or alter its mechanical properties. Clinicians should treat each application as a fresh use to maintain safety and efficacy.

How is DiaTemp Flow activated and applied in a clinical setting, and what makes it suitable for one-piece removal?

DiaTemp Flow is a single-component material that requires light activation for curing, meaning it hardens when exposed to dental curing light. Its flowable nature allows it to be easily placed into prepared cavities, adapting to the tooth structure. The material’s formulation also enables it to be removed in one piece, simplifying application and removal processes for clinicians.

What regulatory pathways has DiaTemp Flow followed, and what does this mean for its use in dental practices?

DiaTemp Flow has undergone FDA 510(k) clearance (K192022) and complies with the Medical Device Directive (MDD). This means it meets the regulatory standards for dental temporary restorative materials in the U.S. and EU markets, ensuring its safety, effectiveness, and adherence to established clinical guidelines for temporary restorations.

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: DiaTemp Flow - Light-Cured Flowable Temporary Restorative ... - DiaDent, DiaTemp Flow - Diadent Europe, Temporary Restorative Material - DiaDent

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diadent Group International

Sources (7)

  • FDA 510(k) K192022 24 fields · synced Sep 18, 2026
  • FDA UDI 65dd04f9-423c-4607-9b64-f328e581675a 36 fields · synced May 30, 2026
  • FDA UDI 015f69b1-ed63-442d-9061-24905b1f9951 36 fields · synced May 30, 2026
  • FDA UDI f34734d4-f044-48c0-abc3-965529323a01 36 fields · synced May 30, 2026
  • EUDAMED da696edb-2baa-46f9-a424-9b8a7f032897 61 fields · synced Jun 20, 2026
  • EUDAMED 8a4b3893-7b48-47d4-b5bc-c16f40fccbda 61 fields · synced Jul 9, 2026
  • EUDAMED f0bc211c-27c3-438a-b111-19d25cb98388 61 fields · synced Jul 10, 2026