Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self

Q: What is the product code of K123278?

The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.

FDA 510(k) K123278 · Heraeus Kulzer, LLC

Substantially Equivalent

510(k) numberK123278

Submission

Device name: Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self
Applicant: Heraeus Kulzer, LLC
South Bend, IN, US
Received: October 22, 2012
Decision date: December 7, 2012
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KLE – Agent, Tooth Bonding, Resin
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3200
Specialty: Dental

Other 510(k)s with product code KLE

510(k)	Device	Applicant	Decision
K260485	Any-EtchKLE · Traditional	Mediclus Co., Ltd.	05/14/2026SE
K260430	Porcelain Etch GelKLE · Traditional	Belport Company, Inc., Gingi-Pak	04/10/2026SE
K252450	Adhese 2KLE · Traditional	Ivoclar Vivadent, Inc.	03/05/2026SE
K260682	Bond-PR Universal AdhesiveKLE · Traditional	Premier Dental Products Company	03/03/2026SE
K251587	VITA VMLC PrimerKLE · Traditional	Vita Zahnfabrik H. Rauter GmbH & Co. Kg.	02/23/2026SE
K252151	els unibondKLE · Traditional	Saremco Dental AG	12/05/2025SE
K252469	Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional	Dmp Dental Industry S.A.	11/06/2025SE
K251124	G-Bond UniversalKLE · Traditional	GC America, Inc.	10/02/2025SE
K242530	HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional	Rizhao Huge Biomaterials Company, Ltd.	12/20/2024SE
K242749	TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional	Rizhao Huge Biomaterials Company, Ltd.	11/08/2024SE

More from Rizhao Huge Biomaterials Company, Ltd.

510(k)	Device	Decision
K130647	Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50MLELW · Traditional	05/17/2013SE
K120914	Flexitime Fast & Scan Light FlowELW · Special	07/25/2012SE
K113574	Flexitime Monophase Pro ScanELW · Traditional	07/13/2012SE
K112501	Venus Pearl PLT Refill A1EBF · Traditional	12/14/2011SE
K111832	Paladon Ultra Powder (Pink), Paladon Ultra LiquidEBI · Traditional	09/29/2011SE
K110037	Palaxpress Ultra Powder (Pink); Palaxpress Ultra LiquidEBI · Traditional	04/29/2011SE
K102770	Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium…ELW · Traditional	12/21/2010SE
K101617	Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge…ELW · Traditional	09/07/2010SE
K093575	Gluma Desensitizer Power GelLBH · Traditional	03/05/2010SE
K091635	Venus Diamond FlowEBF · Abbreviated	09/03/2009SE

Questions and answers

When was Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self cleared by the FDA?

Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self (K123278) received a 510(k) decision of Substantially Equivalent on December 7, 2012, 46 days after the submission was received.

What is the product code of K123278?

The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.