Who else makes this device?

Name: PCA Cement KIT 60GM/40ML
Brand: PCA Cement KIT 60GM/40ML

PCA Cement KIT 60GM/40ML

Catalogue number FP-NOVOINC-143, listed by Septodont, Inc, United States, under Cement, Dental. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

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 PCA Cement KIT 60GM/40ML
Listed by	Septodont, Inc, United States
FDA product code	EMA
Device type	Cement, Dental
Device class	Class 2
Regulation	21 CFR 872.3275
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Record published	2016-09-12
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for PCA Cement KIT 60GM/40ML
Catalogue number	Size	Status
FP-NOVOINC-143		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K771114	1978-01-04
K761354	1977-01-03
K761355	1977-01-03

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.