The following data is part of a premarket notification filed by Merz Dental Gmbh with the FDA for Artbloc Temp, Dimension: 15.5 X19.39 Mm V-classic Shades And Bleach Shades.
| Device ID | K080556 |
| 510k Number | K080556 |
| Device Name: | ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | MERZ DENTAL GMBH 5616 MARIOLA PL NE Albuquerque, NM 87111 |
| Contact | Richard G Hunter, M.s., Rac |
| Correspondent | Richard G Hunter, M.s., Rac MERZ DENTAL GMBH 5616 MARIOLA PL NE Albuquerque, NM 87111 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-28 |
| Decision Date | 2008-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7091017700 | K080556 | 000 |
| D7091017686 | K080556 | 000 |
| D7091017685 | K080556 | 000 |
| D7091017684 | K080556 | 000 |
| D7091017683 | K080556 | 000 |
| D7091017682 | K080556 | 000 |
| D7091017681 | K080556 | 000 |
| D7091017680 | K080556 | 000 |
| D7091017679 | K080556 | 000 |
| D7091017678 | K080556 | 000 |
| D7091017677 | K080556 | 000 |
| D7091017687 | K080556 | 000 |
| D7091017688 | K080556 | 000 |
| D7091017689 | K080556 | 000 |
| D7091017699 | K080556 | 000 |
| D7091017698 | K080556 | 000 |
| D7091017697 | K080556 | 000 |
| D7091017696 | K080556 | 000 |
| D7091017695 | K080556 | 000 |
| D7091017694 | K080556 | 000 |
| D7091017693 | K080556 | 000 |
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| D7091017674 | K080556 | 000 |
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| D7091017659 | K080556 | 000 |
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| D7091017652 | K080556 | 000 |
| D7091017651 | K080556 | 000 |
| D7091017661 | K080556 | 000 |
| D7091017662 | K080556 | 000 |
| D7091017663 | K080556 | 000 |
| D7091017673 | K080556 | 000 |
| D7091017672 | K080556 | 000 |
| D7091017671 | K080556 | 000 |
| D7091017670 | K080556 | 000 |
| D7091017669 | K080556 | 000 |
| D7091017668 | K080556 | 000 |
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| D7091017664 | K080556 | 000 |
| D7091017650 | K080556 | 000 |
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| D7091017732 | K080556 | 000 |
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| D7091017740 | K080556 | 000 |
| D7091017741 | K080556 | 000 |
| D7091017743 | K080556 | 000 |
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| D7091017771 | K080556 | 000 |
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| D7091017728 | K080556 | 000 |
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| D7091017711 | K080556 | 000 |
| D7091017710 | K080556 | 000 |
| D7091017709 | K080556 | 000 |
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| D7091017706 | K080556 | 000 |
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| D7091017703 | K080556 | 000 |
| D7091017702 | K080556 | 000 |
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| D7091017725 | K080556 | 000 |
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| D7091017716 | K080556 | 000 |
| D7091017701 | K080556 | 000 |