Renamel® Flowable Microfill

Renamel® Flowable Microfill Medium Incisal, Syringe 3g

Registry build 21.09.26
1manufacturer
27catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code EBD
Manufacturer City Province Registered as Device types
Yamahachi Dental Material (Changshu) Co., Ltd. Changshu Jiangsu Manufacturer 9

Record

Regulatory record for Renamel® Flowable Microfill
Listed by Deltamed Gmbh, Germany
FDA product code EBD
Device type Coating, Filling Material, Resin
Device class Class 2
Regulation 21 CFR 872.3310
Establishment Manufacturer
510(k) K974494
Record published 2023-05-31

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: avoid direct sunlight; Storage environment temperature 4 to 24 °C

Catalogue Numbers

Catalogue numbers for Renamel® Flowable Microfill
Catalogue number Size Status
301A25 In distribution
3011D3 In distribution
3011DI In distribution
3011OP In distribution
3011C3 In distribution
301A35 In distribution
301A15 In distribution
3011A4 In distribution
30110W In distribution
3011D2 In distribution
3011A6 In distribution
3011B4 In distribution
3011A5 In distribution
3011C4 In distribution
3011C1 In distribution
3011LI In distribution
3011B2 In distribution
3011A3 In distribution
3011A1 In distribution
3011C5 In distribution
3011A2 In distribution
3011B1 In distribution
3011C2 In distribution
3011MI In distribution
3011B3 In distribution
3011LO In distribution
3011D4 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ID Lightcure System ID Korea Co., Ltd. 63
Minute Stain Taub Products 56
Optiglaze™ GC America Inc. 44
Rodin PAC-Dent Inc. 39
Vita Akzent® LC Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft 27
Renamel® Flowable Microfill Cosmedent, Inc. 26
Radica® Dentsply LLC 20
SciPharm Support Self Cured Core Build-Up Restorative Reverse Scientific Pharmaceuticals, Inc. 18
Renamel® Flowable Microhybrid Cosmedent, Inc. 16
Glaze Taub Products 14
Signum matrix Kulzer SRL 14
Minute Stain – L.M.D. Elixirs Taub Products 12

Showing 12 of 100. All products under Coating, Filling Material, Resin

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