Rodin

Rodin™ Luting Cement Syringe - White Opaque (5g)

Registry build 21.09.26
3manufacturers in China registered for this device type
9catalogue numbers in this listing

Who Else Makes It

Concentrated in Shandong (2), Guangdong (1).

Chinese manufacturers registered for FDA product code EMA
Manufacturer City Province Registered as Device types
Shandong Huge Dental Material Corporation Rizhao Shandong Manufacturer 17
Rizhao Huge Biomaterials Company, Ltd. Rizhao Shandong Manufacturer 7
Shenzhen Upcera Dental Technology Co., Ltd. Shenzhen Guangdong Private-label distributor 6

Record

Regulatory record for Rodin
Listed by PAC-Dent Inc., United States
FDA product code EMA
Device type Cement, Dental
Device class Class 2
Regulation 21 CFR 872.3275
Establishment Specification developer, Repacker / relabeller, Manufacturer
510(k) K251775
Record published 2026-03-23

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

Catalogue Numbers

Catalogue numbers for Rodin
Catalogue number Size Status
451102 In distribution
24028 In distribution
451101 In distribution
24030 In distribution
451104 In distribution
451103 In distribution
24027 In distribution
451106 In distribution
24029 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
GC Fuji II LC® GC America Inc. 78
Equia® GC America Inc. 73
Riva SC SDI Ltd. 72
Denture Base American Tooth Industries 61
Riva LC SDI Ltd. 59
GC Fuji IX GP® GC America Inc. 58
GlasIonomer FX-LC Shofu Dental Corp. 45
Henry Schein Henry Schein, Inc. 35
Esthet-X®flow Liquid Micro Hybrid Dentsply LLC 24
Photac™ Fil Quick Aplicap™ 3M Deutschland GmbH 24
Ketac™ Fil Plus Aplicap™ 3M Deutschland GmbH 23
Ultra-Bond® DEN-MAT Holdings, LLC 23

Showing 12 of 780. All products under Cement, Dental

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