FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems
K Number: K252582
·
Decision Nov 18, 2025
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
57
Review Days
95
Basic Information
- Device Name
- Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems
- K Number
- K252582
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Prismatik Dentalcraft, Inc.
- Date Received
- August 15, 2025
- Decision Date
- November 18, 2025
- Product Code
- NHA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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Other Clearances by Prismatik Dentalcraft, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254283 | BruxZir® Shaded 16 PLUS | Jan 30, 2026 | Substantially Equivalent |
| K252446 | BruxZir® NOW | Sep 3, 2025 | Substantially Equivalent |
| K250302 | Flexible Partial Resin | Jun 25, 2025 | Substantially Equivalent |
| K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) | Mar 21, 2025 | Substantially Equivalent |
| K250223 | BruxZir® Esthetic NOW | Feb 25, 2025 | Substantially Equivalent |
| K241493 | Glidewell 3DP Denture Base Resin | Sep 12, 2024 | Substantially Equivalent |
| K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | Jul 12, 2024 | Substantially Equivalent |
| K231940 | BruxZir® NOW SRC | May 15, 2024 | Substantially Equivalent |
| K240882 | BruxZir® Esthetic | May 1, 2024 | Substantially Equivalent |
| K240574 | BruxZir® Radiant | Mar 20, 2024 | Substantially Equivalent |