NobelProcera Titanium ASC Abutment and Omnigrip Clinical Screw Titanium

Device Information

Device Specifications
The NobelProcera Titanium ASC Abutment is a patient-specific dental component customized for prosthetic rehabilitation. It features an angulated screw channel (0°-25°), supporting a cement-retained prosthesis. In addition, the abutment can be angulated to a maximum of 30°. The clinical screw features the Omnigrip Interface, which allows tightening up to 25°. Made from titanium-vanadium alloy (Ti6Al4V ELI), it offers anodized and non-anodized surface options. The Omnigrip Clinical Screw Titanium connects abutments to implants with a secure interface. Both components align with multiple implant platforms sizes.

Indications

The abutments aid in prosthetic rehabilitation by connecting directly to dental implants. They are used to restore patients’ chewing function and aesthetics. The Omnigrip screws secure dental abutments or frameworks to implants in the maxilla or mandible.

Intended Use

The device serves as a prosthetic component for rehabilitation by replacing lost teeth and restoring functionality. It is designed for use by dental professionals in clinical settings.

Availability

Prescription Use only

Study Results

Nonclinical Testing:
- Packaging performance met ASTM D4169 standards.
- Dynamic loading tests followed ISO 14801 and FDA guidelines.
- Magnetic Resonance (MR) compatibility was verified through ASTM protocols.
- Biocompatibility confirmed per ISO 10993-1 standards.
- Cleaning and sterilization validated according to ISO 17665-1.

Regulatory Information

Regulation Number: 21 CFR 872.3630
Regulatory Class: II
Product Code: NHA
All Required Regulations: The device must follow quality system (21 CFR 820) and adverse event reporting requirements (21 CFR 803) and general FDA standards, including labeling and manufacturing practices.

Manufacturer Information

Name: Nobel Biocare AB
Address: Vastra Hamngatan 1, Goteborg 411 17, Sweden.
Contact Person: Bernice Jim, Ph.D.

Predicate Device Information

Primary Predicate: NobelProcera Abutment Titanium (K091756), Omnigrip Clinical Screw CC (K132746)
Reference Devices:
- NobelProcera Angulated Screw Channel Abutment Conical Connection (K132746)
- DESS® Dental Smart Solutions (K221301)
- Universal Abutment NB N1 TCC (K211109)
- NOBELACTIVE WIDE PLATFORM (WP) (K133731)
- Titanium Abutment Blank Nobel Biocare N1™ TCC (K223677)
- NOBELACTIVE MULTI UNIT ABUTMENT (K072570)
- Trefoil System (K170135)
- Nobel Biocare Dental Implant Systems Portfolio – MR Conditional (K212125)
Differences from Predicate:
- The new abutment offers a maximum angulation of 30°, while the predicate device has a limit of 20 °.
- Anodized surfaces are included in the subject device but not in the predicate.