BC 1213 Healing Screw
by Minimatic Implant Technology 510(k)
Active
510(k) K904709
Overview
The BC 1213 Healing Screw is a dental implant classified as an Implant, Endosseous, Root-form (product code DZE). This device is designed for osseointegration within the alveolar bone, providing mechanical stability during the healing phase of dental implant placement.
The BC 1213 Healing Screw is intended for single-use in dental procedures and has received FDA 510(k) clearance under the Traditional review pathway. It was granted Substantially Equivalent status by the Dental (DE) Advisory Committee in 1991 and falls under FDA regulation number 872.3640. No additional sterility or MRI safety information is specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904709 | Date21 Mar 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Minimatic Implant Technology
Questions
What is the BC 1213 Healing Screw used for in dental procedures?
The BC 1213 Healing Screw is designed specifically for osseointegration within the alveolar bone during dental implant placement. It provides mechanical stability to the implant site while the bone heals, ensuring proper integration before further restoration steps.
Is the BC 1213 Healing Screw intended for reuse or single-use?
The BC 1213 Healing Screw is explicitly intended for single-use in dental procedures. This design choice aligns with best practices for maintaining sterility and reducing infection risks during implant surgery.
How was the FDA clearance for this device determined, and what does that mean for clinicians?
The BC 1213 Healing Screw received FDA 510(k) clearance under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) status by the Dental (DE) Advisory Committee in 1991. This means the FDA determined it is as safe and effective as a legally marketed predicate device, allowing clinicians to rely on its established performance for osseointegration in dental implants.
What regulatory pathway and classification does the BC 1213 Healing Screw follow?
The BC 1213 Healing Screw is classified under FDA product code DZE (Implant, Endosseous, Root-form) and was submitted via the Traditional 510(k) review pathway. Its clearance was reviewed by the Dental (DE) Advisory Committee, ensuring compliance with FDA regulations for dental implants.