X-Tra Base

Flowable light-curing base composite. 4 mm restorarion base in one simple step. Perfect furface affinity for outstanding adaption. Low shrinkage stress. High radiocapacity (350 %Al).…

Registry build 21.09.26

Flowable light-curing base composite. 4 mm restorarion base in one simple step. Perfect furface affinity for outstanding adaption. Low shrinkage stress. High radiocapacity (350 %Al). Self-levelling. Can be combined with any methacrylates-based bonding or composite. The non-dripping NDT-syringe or convenient Flow-Caps with bendable metal cannualae ensure a reliable, precisely accurate application.

1manufacturer
3catalogue numbers in this listing
4510(k) clearances naming this product code

Who Else Makes It

Registered in Guangxi.

Chinese manufacturers registered for FDA product code EJK
Manufacturer City Province Registered as Device types
Guilin Kevin Peter Technology Co., Ltd. Guilin Guangxi Manufacturer 13

Record

Regulatory record for x-tra base
Listed by Voco Gmbh, Germany
FDA product code EJK
Device type Liner, Cavity, Calcium Hydroxide
Device class Class 2
Regulation 21 CFR 872.3250
Establishment Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter
Record published 2016-08-31
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature 4 to 23 °C

Catalogue Numbers

Catalogue numbers for x-tra base
Catalogue number Size Per pack Status
1795 16 In distribution
1790 In distribution
1791 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Roeko Calcium Hydroxide Plus Points Coltène/Whaledent AG 15
Hygenic Coltene/Whaledent Gmbh & Co. KG 14
Calcigel Prevest Denpro Limited 8
TheraCal LC Bisco, Inc. 8
Hydroxyline Taub Products 8
GC Fuji Lining™ GC America Inc. 7
TheraCal PT Bisco, Inc. 6
Super Seal Phoenix Dental, Inc. 5
Cal LC Prevest Denpro Limited 4
AxioCAL LC Axiodent Inc. 4
Ultra-Blend Plus Ultradent Products Inc. 4
AxioCAL Axiodent Inc. 4

Showing 12 of 84. All products under Liner, Cavity, Calcium Hydroxide

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K926419 1993-03-31
K924182 1992-10-16
K923849 1992-09-28
K912495 1991-07-30

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer