Precise(R) Beta Quartz Glass-Ceramic Insert
FDA 510(k) K912256 · Lee Pharmaceuticals
510(k) numberK912256
Submission
- Device name
- Precise(R) Beta Quartz Glass-Ceramic Insert
- Applicant
- Lee Pharmaceuticals
South El Monte, CA, US - Received
- May 22, 1991
- Decision date
- July 24, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K924378 | Restobond 4KLE · Traditional | 03/31/1993SE |
| K900809 | Lee-Fischer Ceramic Reinforced Plastic BracketsDYW · Traditional | 06/28/1990SE |
| K894315 | Restobond 3/DENTIN-ENAMEL Bonding AgentKLE · Traditional | 10/31/1989SE |
| K881903 | Prosthodent VLEBF · Traditional | 07/01/1988SE |
| K873123 | Lee Composite Inlay SystemEBF · Traditional | 01/20/1988SE |
| K863157 | Restodent PosteriorEBF · Traditional | 09/25/1986SE |
| K854882 | Protec/Visible Light-Cured Sealant/Dental RestoratEBC · Traditional | 01/30/1986SE |
| K844134 | Cleanse N Bond IIDYH · Traditional | 01/04/1985SE |
| K844133 | Cleanse N Bond IDYH · Traditional | 01/04/1985SE |
| K843363 | Restodent VLEBF · Traditional | 10/25/1984SE |
Questions and answers
When was Precise(R) Beta Quartz Glass-Ceramic Insert cleared by the FDA?
Precise(R) Beta Quartz Glass-Ceramic Insert (K912256) received a 510(k) decision of Substantially Equivalent on July 24, 1991, 63 days after the submission was received.
What is the product code of K912256?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.