PYROLITE CARBON ENDOSSEOUS DENTAL IMPL
FDA 510(k) clearance K791237 · decided 1979-08-28
Clearance details
- K-number
- K791237
- Device name
- PYROLITE CARBON ENDOSSEOUS DENTAL IMPL
- Applicant
- Carbomedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-07-06
- Decision date
- 1979-08-28
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- DZE
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Carbomedics
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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VASCUTEK GELSOFT(TM) VASCULAR GRAFT (P890045/S001) | Carbomedics, Inc. | 1995-07-05 |
| VASCUTEK GELSEAL(TM) VASCULAR GRAFT (P890045/S005) | Carbomedics, Inc. | 1995-04-13 |
| VASCUTEK GELSEAL(TM) VASCULAR GRAFT (P890045/S006) | Carbomedics, Inc. | 1994-07-22 |
| VASCUTEK GELSOFT(TM) VASCULAR GRAFT (P890045/S003) | Carbomedics, Inc. | 1993-12-07 |
| GELSEAL TM TRIAXIAL VASCULAR GRAFT (P890045) | Carbomedics, Inc. | 1993-01-11 |