Who else makes this device?

Name: Proseal
Brand: Proseal

Dental › ProstheticCoating, Filling Material, Resin

Proseal

LED PRO SEAL® is intended for use as an enamel surface sealant around orthodontic brackets. LED PRO SEAL® can be illuminated or“revealed” on the tooth surface to check application using a…

Registry build 21.09.26

LED PRO SEAL® is intended for use as an enamel surface sealant around orthodontic brackets. LED PRO SEAL® can be illuminated or“revealed” on the tooth surface to check application using a Reliance Black Light or a simple portable (UV) light. Cures using a 468nm LED Light. 6ml bottle LED ProSeal

1manufacturer

5catalogue numbers in this listing

1510(k) clearance

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 Proseal
Listed by	Reliance Orthodontic Products, Inc., United States
FDA product code	EBD
Device type	Coating, Filling Material, Resin
Device class	Class 2
Regulation	21 CFR 872.3310
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K021503
Record published	2026-02-20
Record revised	2018-07-06 (version 3)

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
Storage	Special storage condition: Store at room temperature (15-30 Degrees C)

Catalogue Numbers

Catalogue numbers for Proseal
Catalogue number	Size	Status
1PROSY		In distribution
PRO		In distribution
1PROSY		In distribution
PROSY		In distribution
LEDPRO		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
Renamel® Flowable Microfill	Deltamed Gmbh	27
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

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K073243	2008-02-08

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.