510(k) K060530
- Device
- SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.
- Applicant
- LIFECORE BIOMEDICAL, INC.
- 510(k) number
- K060530
- Product code
- ELL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-05-22
- Date received
- 2006-02-28
- Regulation
- 872.3920
- Classification name
- Teeth, Porcelain
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RACHEL KENNEDY
- Address
- 3515 Lyman Blvd. Chaska MN US 55318 55318
FDA Registration Numbers#
- 3009496224
- 3006191485
- 3008693672
- 3005895657
- 1219645
- 3011936113
- 3005974404
- 3005031178
- 3009482106
- 3023272670
- 3007740664
- 3010127342
- 3004966444
- 9612352
- 2511556
- 1000625496
- 1000277456
- 3002808149
- 3038718579
- 9611992
- 3009161350
- 3008792854
- 3003929447
- 3011511773
- 3006059056
- 3028011
Source Documents#
Other 510(k) Records For Product Code ELL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240586 | Additive Manufacturing Zirconia Customized Restoration | Hangzhou Thales Medtech Co., Ltd. | 2024-10-03 |
| K203072 | Franz Zirconia Dental Crown | Franz Biotech, Inc. | 2022-01-19 |
| K162043 | NobelProcera HT ML FCZ Bridge | Nobel Biocare AB | 2016-11-22 |
| K153534 | NobelProcera HT ML Full Contour Zirconia Crown | Nobel Biocare AB | 2016-06-06 |
| K071182 | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 | Nobel Biocare AB | 2007-07-11 |
| K041283 | PROCERA BRIDGE ZIRCONIA | Nobel Biocare AB | 2004-05-28 |
| K032562 | PROCEARA COPINGS AND PONTIC | Nobel Biocare AB | 2004-02-06 |
| K965216 | ARGI-SATIN OR OPTI0-STAR | Argen Precious Metals, Inc. | 1997-02-27 |
| K960770 | MATCHMAKER/PROPAQUE PORCELAIN | Davis Schottlander & Davis, Ltd. | 1996-11-19 |
| K960480 | IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 | Vident | 1996-03-15 |
| K930835 | VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A | Ivoclar North America, Inc. | 1994-07-22 |
| K932012 | CAPS | Chemichl, Inc. | 1993-11-03 |
| K931808 | DUCERAGOLD, DUCERATIN | Degussa AG | 1993-11-03 |
| K924823 | MICRODOSE SILANE | Unicep | 1993-03-16 |
| K924821 | MICRODOSE PORCELAIN ETCHANT | Unicep | 1993-03-16 |
Legacy Summary#
summary
FDA Review#
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