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Visalys® Bulk Fill 1 x 4 g Syringe (15060) +5 more models

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K250267Ref 15067

by Kettenbach GmbH & Co. KG

Identity

Trade Name
Visalys Bulk Flow Intro pack EUDAMED
Visalys Bulk Flow FDA UDI
Generic Name
Dental composite resin FDA UDI
Device Name
Visalys Bulk Flow EUDAMED
Visalys Bulk Flow Intro pack, 2 x 0.25 g Caps FDA UDI
Model / Reference
15067 EUDAMEDFDA UDI
Description
Visalys Bulk Flow Intro pack, 2 x 0.25 g Caps FDA UDI

Identifiers

Catalog Number
15067 FDA UDI
Primary DI / UDI-DI
E21715067 EUDAMED
E217150671 FDA UDI
Basic UDI-DI
++E217VBULK74 EUDAMED
510(k) Number
K250267 FDA 510(k)FDA UDI
FDA Product Code
EBF FDA 510(k)FDA UDI
EMDN Code
Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
GMDN Term
Dental composite resin FDA UDI
Models / Variants
Visalys® Bulk Fill 1 x 4 g Syringe (15060) FDA 510(k)FDA UDIEUDAMED
Visalys® Bulk Fill 15 x 0.25 g Caps (15062) FDA 510(k)FDA UDIEUDAMED
Visalys® Bulk Flow 1 x 2 g Syringe (15064) FDA 510(k)FDA UDIEUDAMED
Visalys® Bulk Flow 15 x 0.25 g Caps (15066) FDA 510(k)FDA UDIEUDAMED
Visalys® Bulk Flow Intro pack (15067) FDA 510(k)FDA UDIEUDAMED
Visalys® Bulk Intro pack (15068) FDA 510(k)FDA UDIEUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)FDA UDI
Market of Registration
Germany 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

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

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

The Visalys Bulk Fill and Bulk Flow systems are dental composite materials designed for bulk-fill and flowable applications in restorative procedures. These materials are formulated to facilitate efficient placement in larger cavity preparations while maintaining mechanical properties and aesthetic outcomes.

The syringes and caps are supplied as single-use components, intended for use in dental clinics and offices. Each product is packaged sterile and requires no additional sterilisation, with sizes specified to match clinical workflows. The devices are authorised under FDA 510(k) and MDR regulations, adhering to dental product standards for safety and performance.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kettenbach GmbH & Co. KG

Sources (3)

  • FDA 510(k) K250267 24 fields · synced Oct 6, 2026
  • FDA UDI c82860e2-f580-457a-be79-30163560db42 37 fields · synced May 30, 2026
  • EUDAMED 66755625-0196-4976-bfd8-e728667ce53e 61 fields · synced Jul 10, 2026