Who else makes this device?

Name: Futurabond NR
Brand: Futurabond NR

Dental › ProstheticAgent, Tooth Bonding, Resin

Futurabond NR

Light-curing self-etch-bond reinforced with nano-fillers. Excellent adhesion to dentine and enamel. Durable marginal integrity. Moisture-tolerant. Easy and fast application - on-coat,…

Registry build 21.09.26

Light-curing self-etch-bond reinforced with nano-fillers. Excellent adhesion to dentine and enamel. Durable marginal integrity. Moisture-tolerant. Easy and fast application – on-coat, one-cure technique. Universal for all light-curing restoratives. Ideal for paediatric use. Contains fluorides. No refrigerated storage needed.

6manufacturers in China registered for this device type

3catalogue numbers in this listing

10510(k) clearances naming this product code

1recall

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 Futurabond NR
Listed by	Voco Gmbh, Germany
FDA product code	KLE
Device type	Agent, Tooth Bonding, Resin
Device class	Class 2
Regulation	21 CFR 872.3200
Establishment	Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter
Record published	2016-08-31
Record revised	2024-02-16 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 4 to 23 °C

Catalogue Numbers

Catalogue numbers for Futurabond NR
Catalogue number	Per pack	Status
1152	50	In distribution
1153	200	In distribution
1148		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
K141610	2014-08-01
K130486	2013-06-20
K082753	2008-11-24
K070723	2007-06-07
K053392	2005-12-15
K042670	2004-11-01
K030844	2003-06-13
K003153	2000-11-15
K980539	1998-03-23
K924181	1992-10-16

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-11-03	Class II	Labeling mix-ups	Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive.	50 units	2017-08-23

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.