The following data is part of a premarket notification filed by Talladium, Inc. with the FDA for Luminesse Porcelain System.
Device ID | K140848 |
510k Number | K140848 |
Device Name: | LUMINESSE PORCELAIN SYSTEM |
Classification | Powder, Porcelain |
Applicant | TALLADIUM, INC. 27360 WEST MUIRFIELD LN. Valencia, CA 91355 |
Contact | Edward R Harms |
Correspondent | Edward R Harms TALLADIUM, INC. 27360 WEST MUIRFIELD LN. Valencia, CA 91355 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-03 |
Decision Date | 2014-12-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D7911906Y0 | K140848 | 000 |
D7911913A00 | K140848 | 000 |
D7911913A10 | K140848 | 000 |
D7911913A20 | K140848 | 000 |
D7911913A30 | K140848 | 000 |
D7911913A40 | K140848 | 000 |
D7911913B00 | K140848 | 000 |
D7911913B10 | K140848 | 000 |
D7911913B20 | K140848 | 000 |
D7911913B30 | K140848 | 000 |
D7911913B40 | K140848 | 000 |
D7911913C10 | K140848 | 000 |
D7911913C20 | K140848 | 000 |
D7911913C30 | K140848 | 000 |
D7911912B20 | K140848 | 000 |
D7911912B10 | K140848 | 000 |
D7911912A10 | K140848 | 000 |
D7911907B0 | K140848 | 000 |
D7911907C0 | K140848 | 000 |
D7911907G0 | K140848 | 000 |
D7911907N0 | K140848 | 000 |
D7911907O0 | K140848 | 000 |
D7911908MBL0 | K140848 | 000 |
D7911908MBR0 | K140848 | 000 |
D7911908MO0 | K140848 | 000 |
D7911909A10 | K140848 | 000 |
D7911909A20 | K140848 | 000 |
D7911909A30 | K140848 | 000 |
D7911909A40 | K140848 | 000 |
D79119110 | K140848 | 000 |
D7911913D20 | K140848 | 000 |
D7911913D30 | K140848 | 000 |
D7911951D30 | K140848 | 000 |
D7911951D40 | K140848 | 000 |
D7911952A00 | K140848 | 000 |
D7911952A10 | K140848 | 000 |
D7911952A20 | K140848 | 000 |
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D7911952A350 | K140848 | 000 |
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D7911951C40 | K140848 | 000 |
D7911951C30 | K140848 | 000 |
D7911913D40 | K140848 | 000 |
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D7911951A20 | K140848 | 000 |
D7911951A30 | K140848 | 000 |
D7911951A350 | K140848 | 000 |
D7911951A40 | K140848 | 000 |
D7911951B0 | K140848 | 000 |
D7911951B10 | K140848 | 000 |
D7911951B20 | K140848 | 000 |
D7911951B30 | K140848 | 000 |
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D7911951C10 | K140848 | 000 |
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D7911900ST1500 | K140848 | 000 |
D7911900ST2500 | K140848 | 000 |
D7911900ST3500 | K140848 | 000 |
D7911900ST4500 | K140848 | 000 |
D7911900T1500 | K140848 | 000 |
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D7911902A10 | K140848 | 000 |
D7911902A20 | K140848 | 000 |
D7911902A30 | K140848 | 000 |
D7911902A350 | K140848 | 000 |
D7911900C4500 | K140848 | 000 |
D7911900C3500 | K140848 | 000 |
D7911900C2500 | K140848 | 000 |
D7911900A0500 | K140848 | 000 |
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D7911900A2500 | K140848 | 000 |
D7911900A3500 | K140848 | 000 |
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D7911900B2500 | K140848 | 000 |
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D7911906C0 | K140848 | 000 |
D7911906D0 | K140848 | 000 |
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D7911906DBL0 | K140848 | 000 |
D7911906DP0 | K140848 | 000 |
D7911906GY0 | K140848 | 000 |
D7911906LB0 | K140848 | 000 |
D7911906O0 | K140848 | 000 |
D7911906OL0 | K140848 | 000 |
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D7911963D40 | K140848 | 000 |
D7911972A00 | K140848 | 000 |
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D791197310 | K140848 | 000 |
D791197320 | K140848 | 000 |
D7911979M10 | K140848 | 000 |
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D7911979M30 | K140848 | 000 |
D7911979M40 | K140848 | 000 |
D7911979M60 | K140848 | 000 |
D7911980BR0 | K140848 | 000 |
D7911980C0 | K140848 | 000 |
D7911980O0 | K140848 | 000 |
D7911980R0 | K140848 | 000 |
D7911980Y0 | K140848 | 000 |
D7911981DP0 | K140848 | 000 |
D7911981LP0 | K140848 | 000 |
D7917120 | K140848 | 000 |
D7911978Y0 | K140848 | 000 |
D7911978OC0 | K140848 | 000 |
D7911978O0 | K140848 | 000 |
D791197330 | K140848 | 000 |
D791197340 | K140848 | 000 |
D7911973B0 | K140848 | 000 |
D7911977B0 | K140848 | 000 |
D7911977C0 | K140848 | 000 |
D7911977G0 | K140848 | 000 |
D7911977N0 | K140848 | 000 |
D7911977O0 | K140848 | 000 |
D7911977OB0 | K140848 | 000 |
D7911977OO0 | K140848 | 000 |
D7911977P0 | K140848 | 000 |
D7911977W0 | K140848 | 000 |
D7911978I0 | K140848 | 000 |
D7917340 | K140848 | 000 |
D7911952C10 | K140848 | 000 |
D7911957G0 | K140848 | 000 |
D7911957O0 | K140848 | 000 |
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D7911957OO0 | K140848 | 000 |
D7911957P0 | K140848 | 000 |
D7911957W0 | K140848 | 000 |
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D7911958Y0 | K140848 | 000 |
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D7911957B0 | K140848 | 000 |
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D7911952C30 | K140848 | 000 |
D7911952C40 | K140848 | 000 |
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D7911953C0 | K140848 | 000 |
D7911953N0 | K140848 | 000 |
D7911954G0 | K140848 | 000 |
D7911954GP0 | K140848 | 000 |
D7911959M40 | K140848 | 000 |
D7911959M50 | K140848 | 000 |
D7911962C10 | K140848 | 000 |
D7911962C20 | K140848 | 000 |
D7911962C30 | K140848 | 000 |
D7911962C40 | K140848 | 000 |
D7911962D20 | K140848 | 000 |
D7911962D30 | K140848 | 000 |
D7911962D40 | K140848 | 000 |
D7911963A10 | K140848 | 000 |
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D7911963A30 | K140848 | 000 |
D7911963A350 | K140848 | 000 |
D7911963A40 | K140848 | 000 |
D7911963B0 | K140848 | 000 |
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D7911962B30 | K140848 | 000 |
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D7911960BR0 | K140848 | 000 |
D7911960O0 | K140848 | 000 |
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D7911960Y0 | K140848 | 000 |
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D7911961LF0 | K140848 | 000 |
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D7911962A30 | K140848 | 000 |
D7911962A350 | K140848 | 000 |
D7911962A40 | K140848 | 000 |
D7911962B10 | K140848 | 000 |
D7911963B10 | K140848 | 000 |