Simple
FDA 510(k) K013519 · Bisco, Inc.
510(k) numberK013519
Submission
- Device name
- Simple
- Applicant
- Bisco, Inc.
Schaumburg, IL, US - Received
- October 23, 2001
- Decision date
- January 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
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| 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 |
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| K182917 | FluoroCalLBH · Traditional | 11/18/2019SE |
| K180344 | TheraCal DCEJK · Special | 04/05/2018SE |
| K171147 | REVEAL BulkEBF · Traditional | 08/04/2017SE |
| K162598 | HAPI SealEBC · Traditional | 05/23/2017SE |
| K163171 | CeraCleanPME · Traditional | 04/14/2017SE |
| K161051 | All-Bond Universal w/BAC (not finalized)KLE · Traditional | 09/09/2016SE |
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Questions and answers
When was Simple cleared by the FDA?
Simple (K013519) received a 510(k) decision of Substantially Equivalent on January 17, 2002, 86 days after the submission was received.
What is the product code of K013519?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.