Hema-Benz
FDA 510(k) K953405 · Health-Dent Intl., Inc.
510(k) numberK953405
Submission
- Device name
- Hema-Benz
- Applicant
- Health-Dent Intl., Inc.
Northlake, IL, US - Received
- July 20, 1995
- Decision date
- September 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| 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 |
|---|---|---|
| K972198 | Dent-Temp AcrylicEBG · Traditional | 12/17/1997SE |
| K951220 | Hema-GluKLE · Traditional | 05/12/1995SE |
| K951381 | VilaDYH · Traditional | 04/27/1995SE |
| K951380 | Vila PCDYH · Traditional | 04/27/1995SE |
| K951235 | GirocDYH · Traditional | 04/20/1995SE |
| K951236 | Pro-LockDYH · Traditional | 04/18/1995SE |
| K951237 | Algi-BandELW · Traditional | 04/10/1995SE |
Questions and answers
When was Hema-Benz cleared by the FDA?
Hema-Benz (K953405) received a 510(k) decision of Substantially Equivalent on September 27, 1995, 69 days after the submission was received.
What is the product code of K953405?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.