SPECTRA SYSTEM DENTAL IMPLANTS 2008
FDA 510(k) clearance K090234 · decided 2009-05-15
Clearance details
- K-number
- K090234
- Device name
- SPECTRA SYSTEM DENTAL IMPLANTS 2008
- Applicant
- Implant Direct, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-01-30
- Decision date
- 2009-05-15
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Calabasas, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Implant Direct
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UNIQA® Dental Implants System (K251188) | Uniqa Dental, Ltd. | 2026-06-25 |
| MegaGen Zygoma Dental Implant System (K251232) | Megagen Implant Co., Ltd. | 2026-06-18 |
| Dental Implant System (K250806) | A.B. Dental Devices , Ltd. | 2026-06-18 |
| INOSS System (K260006) | Inosys, Inc. | 2026-06-17 |
| Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant (K252731) | Promimic AB | 2026-05-12 |
| Adin Long Dental Implant System (K252031) | Adin Dental Implant Systems , Ltd. | 2026-03-23 |
| ZENEX Implant System_Short (R-System) (K253334) | Izenimplant Co., Ltd. | 2026-03-16 |
| Straumann® BLC Implants - Indication Widening (K252168) | Institut Straumann AG | 2026-03-10 |
| Dentis SQ-SL AXEL Fixture (K253493) | Dentis Co., Ltd. | 2026-03-04 |
| Nobel Biocare S Series Implants (K252197) | Nobel Biocare AB | 2026-02-18 |
| BIORES Dental Implant System (K252286) | Chengdu Besmile Medical Technology Co., Ltd. | 2026-02-02 |
| ZENEX Implant System_R-System (K252585) | Izenimplant Co., Ltd. | 2026-01-08 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x recall (Z-1157-2020) | Implant Direct Sybron Manufacturing LLC | 2020-02-05 |
| Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 recall (Z-1041-2020) | Implant Direct Sybron Manufacturing LLC | 2020-02-04 |
| Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform recall (Z-0364-2020) | Implant Direct Sybron Manufacturing, LLC | 2019-11-12 |
| SwishTapered Implant recall (Z-1112-2017) | Implant Direct Sybron Manufacturing, LLC | 2017-01-28 |
| GoDirect Screw-Retaining Top Part Numbers: 4500-61 recall (Z-0961-2017) | Implant Direct Sybron Manufacturing, LLC | 2017-01-09 |