Who else makes this device?

Name: EU College Kit
Brand: EU College Kit

Dental › ProstheticAgent, Tooth Bonding, Resin

EU College Kit

The University College Kit includes 1 syringe Ultra Band Lok Blue NonFluoride, 1 syringe GoTo bracket adhesive, 1 x 2ml bottle Assure Plus Universal Bonding Resin, 1 x Flowtain syringe for…

Registry build 21.09.26

The University College Kit includes 1 syringe Ultra Band Lok Blue NonFluoride, 1 syringe GoTo bracket adhesive, 1 x 2ml bottle Assure Plus Universal Bonding Resin, 1 x Flowtain syringe for lingual retention, Ortho FlexTech and Retainium Lingual retainer wires and Technical Bonding Cards

6manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jilin (2), Liaoning (1), Guangdong (1).

Chinese manufacturers registered for FDA product code KLE
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
CAO (China) Medical Equipment Company, Limited	Langfang	Hebei	Contract manufacturer	6
Sincera Technology (Changchun) Co., Ltd.	Changchun	Jilin	Manufacturer	2
Sino-Dentex Co., Ltd.	Changchun	Jilin	Manufacturer	2

Record

Regulatory record for EU College Kit
Listed by	Reliance Orthodontic Products, Inc., United States
FDA product code	KLE
Device type	Agent, Tooth Bonding, Resin
Device class	Class 2
Regulation	21 CFR 872.3200
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Record published	2019-04-04
Record revised	2024-02-16 (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
Storage	Special storage condition: Store at room temperature (15-30 Degrees C) Avoid excessive heat.

Catalogue Numbers

Catalogue numbers for EU College Kit
Catalogue number	Size	Status
EUUNIVHAND		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Epic®	Parkell, Inc.	22
All-Bond Universal	Bisco, Inc.	18
Henry Schein	Henry Schein, Inc.	16
Peak Universal Bond	Ultradent Products Inc.	16
Brush&Bond®	Parkell, Inc.	16
All-Bond 2	Bisco, Inc.	15
The Orthodontic Store	Young Innovations Inc.	15
All-Bond 3	Bisco, Inc.	13
Scotchbond™ Universal	3M Deutschland GmbH	13
Select HV Etch w/BAC	Bisco, Inc.	12
Prelude	Danville Materials, LLC	12
Jade	Dharma Research, Inc.	12

Showing 12 of 609. All products under Agent, Tooth Bonding, Resin

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K210945	2021-07-08
K071688	2007-09-07

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.