What is FDA product code PME?

For use on dental restorations, external to the mouth, prior to insertion into the mouth.

Resolve Cleansing Gel · External Cleaning Solution → Dental

Name: Resolve Cleansing Gel
Brand: Resolve Cleansing Gel

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

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

Chinese manufacturers registered for FDA product code PME
Manufacturer	City	Province	Registered as	Device types
Liaoning Upcera Co., Ltd.	Benxi	Liaoning	Contract manufacturer	10
Shenzhen Upcera Digital Dental Technology Co., Ltd.	Shenzhen	Guangdong	Exporter	10
Rizhao Huge Biomaterials Company, Ltd.	Rizhao	Shandong	Manufacturer	7

Record

Regulatory record for Resolve Cleansing Gel
Listed by	Denali Corporation, United States
FDA product code	PME
Device type	External Cleaning Solution
Device class	Class 2
Regulation	21 CFR 872.3260
Record published	2016-08-04
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Packaging	Pack of 2

Catalogue Numbers

Catalogue numbers for Resolve Cleansing Gel
Catalogue number	Size	Status
Single – Pink		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Go-CHx Gel – 0.8% Chlorhexidine	Taub Products	3
ZirClean	Bisco, Inc.	2
UniClean	Vista Dental	1
Detail™ Pre-Impression Cleansing Gel	Clinician’S Choice Dental Products, Inc.	1
ZrC Syringe Kit	Vista Dental	1
ZrC Bottle	Vista Dental	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K152322	2015-12-16

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.

Resolve Cleansing Gel