S.S. White-Pennwalt Prelude Pit Sealant
FDA 510(k) K801274 · Pennwalt Corp.
510(k) numberK801274
Submission
- Device name
- S.S. White-Pennwalt Prelude Pit Sealant
- Applicant
- Pennwalt Corp.
Mchenry, IL, US - Received
- May 29, 1980
- Decision date
- June 9, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EBC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260819 | Any-Com SealEBC · Traditional | Mediclus Co., Ltd. | 05/01/2026SE |
| K243254 | Parkell Pit and Fissure SealantEBC · Abbreviated | Parkell, Inc. | 08/08/2025SE |
| K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioEBC · Traditional | Ultradent Product, Inc. | 08/18/2023SE |
| K230455 | Enamel Coating ResinEBC · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 07/25/2023SE |
| K190998 | BA Pit & Fissure SealantEBC · Abbreviated | Apex Dental Materials, Inc. | 11/08/2019SE |
| K190339 | Helioseal F PlusEBC · Abbreviated | Ivoclar Vivadent, AG | 07/29/2019SE |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCPEBC · Traditional | Pulpdent Corporation | 01/05/2018SE |
| K171330 | Nanova SealantEBC · Traditional | Nanova Biomaterials, Inc. | 09/08/2017SE |
| K162598 | HAPI SealEBC · Traditional | Bisco, Inc. | 05/23/2017SE |
| K161580 | Premier SealantEBC · Traditional | Premier Dental Company Products | 10/18/2016SE |
More from Premier Dental Company Products
| 510(k) | Device | Decision |
|---|---|---|
| K833241 | IntrexEAP · Traditional | 10/28/1983SE |
| K801860 | S.S. White-Pennwalt Renew Calcium HydroxEJK · Traditional | 10/10/1980SE |
| K800133 | Panorex II Dental X-Ray UnitEHD · Traditional | 03/03/1980SE |
| K800063 | XR-710EAP · Traditional | 03/03/1980SE |
| K780981 | Portable Pneumatic Calibrator 65-150BXX · Traditional | 08/02/1978SE |
Questions and answers
When was S.S. White-Pennwalt Prelude Pit Sealant cleared by the FDA?
S.S. White-Pennwalt Prelude Pit Sealant (K801274) received a 510(k) decision of Substantially Equivalent on June 9, 1980, 11 days after the submission was received.
What is the product code of K801274?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.