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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 9550 San Mateo Blvd NE Ste C, ALBUQUERQUE, NM, 87113
- Website
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- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 1627417
- DUNS Number
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Catalogue (745)
Page 8 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Small Diameter Dental Implant | SDI | FDA UDI | Class II | Active |
| One Piece O-Ball Dental Implant | O-Ball | FDA UDI | Class II | Active |
| Bone Level UCLA | 3.25mm UCLA | FDA UDI | Class II | Active |
| Implant Driver | Implant Driver Short 3.25mm | FDA UDI | Class I | Active |
| Isi Analog | 3.0MM, 3.25MM CROWN & BRIDGE O-BALL ANALOG FLAT ON CB SIDE | FDA UDI | Class I | Active |
| Ucla Non Engaging Delrin | 4.0MM TSI/ERI DELRIN UCLA ABUTMENT NON-ENGAGING | FDA UDI | Class II | Active |
| TSI/ERI Indexing Impression Coping | 5mm TSI/ERI Indexing Impression Coping | FDA UDI | Class I | Active |
| Osteotomy Former | 3.3mm Osteotomy Former | FDA UDI | Class I | Active |
| Cb Trip | 5.0mm CB TRIP ISI &TSI | FDA UDI | Class I | Active |
| Multipeg | MUTLIPEG FOR PENGUIN RFA 4.0/5.0MM TSI | FDA UDI | Class I | Active |
| Bone Level UCLA | 3.25mm UCLA | FDA UDI | Class II | Active |
| Two-Stage Dental Implant | TSI | FDA UDI | Class II | Active |
| 3.25mm O-Ball Abutment | TSI/ERI O-Ball Abutment | FDA UDI | Class II | Active |
| Tsi Analog | 3.25mm TSI ANALOG3.25MM | FDA UDI | Class I | Active |
| Bone Level Locator Abutment | 3.25mm Locator Abutment | FDA UDI | Class II | Active |
| Two-Stage Dental Implant | TSI | FDA UDI | Class II | Active |
| Two Stage Bone Level Dental Implant | Engage | FDA UDI | Class II | Active |
| Bone Level Locator Abutment | 4mm Locator Abutment | FDA UDI | Class II | Active |
| Retention Pin | Guided Surgery Retention Pins | FDA UDI | Class I | Active |
| Lok Insert Pack | TRANSPARENT CLEAR SILICONE INSERT 4 LB RETENTION 4PK | FDA UDI | Class I | Active |
| Bone Level Healing Abutment | 4mm Healing Abutment | FDA UDI | Class II | Active |
| Bone Level Locator Abutment | 3.25mm Locator Abutment | FDA UDI | Class II | Active |
| Pilot Drill | 1.8mm Guided Surgery Pilot Drill 15mm | FDA UDI | Class I | Active |
| Drill Stop | Drill Stop For 0350T and 0370T, 12mm | FDA UDI | Class I | Active |
| Housing Cap With White O-Ring | 003 CAP WITH 003 WHT O-RING INSERTED | FDA UDI | Class I | Active |
| Guided Sleeve | 5.0MM GUIDED SURGERY SLEEVE | FDA UDI | Class I | Active |
| Drill Stop Kit | DRILL STOP KIT | FDA UDI | Class I | Active |
| Offset Abutment Spline | 5.0mm OFFSET SHIELD ABUTMENT-SHORT SPLINE | FDA UDI | Class II | Active |
| Bone level Locator Abutment | 6mm Locator Abutment | FDA UDI | Class II | Active |
| Custom Tsi Analog | 3.25mm CUSTOM TSI ANALOG | FDA UDI | Class I | Active |
| Bone Level Locator Abutment | 6mm Locator Abutment | FDA UDI | Class II | Active |
| Floor Drill | 5.0 SINUS FLOOR DRILL | FDA UDI | Class I | Active |
| Tsi Impression Coping Spline | 5.0mm TSI/ERI INDEXING IMPRESSION COPING TITANIUM | FDA UDI | Class I | Active |
| TSI/ERI Custom Abutment | TSI/ERI Transmucosal Abutment 4mm & 5mm | FDA UDI | Class II | Active |
| Bone Level Implant Abutment | 4mm Crown & Bridge Abutment | FDA UDI | Class II | Active |
| Two Stage Bone Level Implant | Engage Plus | FDA UDI | Class II | Active |
| Ridge Mapping Caliper | Ridge Mapping Caliper | FDA UDI | Class I | Active |
| Pilot Drill | 1.8mm Guided Surgery Pilot Drill 25mm | FDA UDI | Class I | Active |
| Offset Osteotome | 1.8mm Offset Osteotome | FDA UDI | Class I | Active |
| Engage Tibase Short | 5.0 ENGAGE TIBASE SHORT | FDA UDI | Class II | Active |
| TSI/ERI/Macro Locator | Locator Inserts-4 Pack | FDA UDI | Class II | Unknown |
| Healing Abutment Slim | 5.0MM ENGAGE HEALING ABUTMENT 4.5MM PLATFORM, 3MM LENGTH (SLIM) | FDA UDI | Class II | Active |
| Two Stage Bone Level Implant | Engage Plus | FDA UDI | Class II | Active |
| SDI Driver | 2.2/2.5mm SDI Driver (Long) | FDA UDI | Class I | Active |
| Scan Body | 5.0MM ENGAGE SCAN BODY | FDA UDI | Class I | Active |
| Tsi Ucla Non Engaging Tibase | 5.0mm TSI/ERI TITANIUM BASE UCLA ABUTMENT NON-ENGAGING | FDA UDI | Class II | Active |
| Multi Unit Pin | MULTI-UNIT INCLUSIVE GUIDE PIN | FDA UDI | Class I | Active |
| Two Stage Bone Level Dental Implant | Engage | FDA UDI | Class II | Active |
| Handpiece Driver Adapter | Handpiece Driver Adapter | FDA UDI | Class I | Active |
| Bone Level Locator Abutment | 5mm Locator Abutment | FDA UDI | Class II | Active |
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