kulzer-dental.comCoating Material
SUN MEDICAL CO., LTD
SUN MEDICAL CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8030419 | 3002973484 | SUN MEDICAL CO., LTD. | 1 | N | 2026-01-01 | 571-2 Furutaka-cho Moriyama Shiga JP 524-0044 |
| 1627662 | 1627662 | SUN MEDICAL, INC. | 1 | N | 2020-04-25 | 7112 Sandy Lake Rd Quinlan TX US 75474 |
| 8030419 | 3002973484 | SUN MEDICAL CO., LTD. | 1 | N | 2020-04-25 | 571-2 FURUTAKA-CHO MORIYAMA Siga JP 524-0044 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04560227803403 | iCEM Universal Plus - iCEM Universal Plus Cement Value Pack Translucent | +1(800)431-1785 | customerservice.na@kulzer-dental.com |
| 04560227803410 | iCEM Universal Plus - iCEM Universal Plus Cement Value Pack Opaque | +1(800)431-1785 | customerservice.na@kulzer-dental.com |
| 04560227803427 | iCEM Universal Plus - iCEM Universal Plus Primer Value Pack | +1(800)431-1785 | customerservice.na@kulzer-dental.com |
| 04560227803434 | iCEM Universal Plus - iCEM Universal Plus Cement Translucent | +1(800)431-1785 | customerservice.na@kulzer-dental.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 10602 | 1801144503 | K994302 | RESIN TOOTH BONDING AGENT | KLE | 2000-02-07 |
| 10602 | 1497511261 | K990381 | TOTALBOND | EMA | 1999-05-17 |
| 10602 | 1052476815 | K964867 | HYBRID RESIN COMPOSITE | KLE | 1997-04-11 |
| 10602 | 1611963699 | K960879 | AMALGAMIBOND PLUS | KLE | 1996-03-22 |
| 10602 | 1667909178 | K960464 | C & B METABOND (MODIFICATION) | EMA | 1996-02-26 |
| 10602 | 1015108158 | K952123 | MS EMULSION | KLE | 1995-06-20 |
| 10602 | 1309716725 | K942017 | V-PRIMER | KLE | 1994-07-06 |
| 10602 | 1094931303 | K923867 | METAFIL | EBF | 1992-10-06 |
| 32252 | 1994351519 | K911154 | SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 | FYD | 1991-07-26 |
| 10602 | 1082017578 | K900303 | CONNECT | EMA | 1990-04-12 |
| 10602 | 1012053282 | K896719 | PRIMER-P ADHESIVE AGENT | EBI | 1990-02-22 |
| 346353 | 1834919130 | K254063 | iCEM Universal Plus | EMA | 2025-12-19 |
| 10602 | 1883046519 | K151518 | BRUSH&BOND PLUS | KLE | 2015-09-18 |
| 10602 | 1549311045 | K142848 | EAZY PRIMER | KLE | 2015-02-24 |
| 10602 | 1317629151 | K073698 | SECURE | EMA | 2008-03-19 |
| 10602 | 1832584019 | K060946 | CZ-S2000 | KIF | 2006-06-15 |
| 10602 | 1691609775 | K020239 | TOUCH&BOND-PLUS | KLE | 2002-03-20 |
| 32252 | 1742857645 |
Product Codes Associated With Registrations#
PMN#
Acrylic Block
SUN MEDICAL CO., LTD.
SUN MODEL OA 3000 OXYGEN ANALYZER
SUN MEDICAL EQUIPMENT, INC.
DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900
SUN MEDICAL, INC.
SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200
SUN MEDICAL, INC.
SUN MEDICAL SMOKE EVACUATOR SYSTEM
SUN MEDICAL, INC.
SUN MEDICAL LAMINARIA CERVICAL DILATOR
SUN MEDICAL, INC.
GUDID#
iCEM Universal Plus - iCEM Universal Plus Primer
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Cement Opaque
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Cement Yellow
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Cement White
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Cement Translucent
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Primer Value Pack
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Cement Value Pack Opaque
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Cement Value Pack Translucent
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Trial Kit
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Endo Tips
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Mixing Tips
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Endo Tips
2026-02-09
iCEM Universal Plus - iCEM Universal Plus Mixing Tips
2026-02-09
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 232 mm length x 192 mm width x 35 mm depth, and the color type is Dark Pink.
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 232 mm length x 192 mm width x 35 mm depth, and the color type is Pink.
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 232 mm length x 192 mm width x 35 mm depth, and the color type is Light Pink.
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 98.5 mm diameter x 30 mm depth, and the color type is Dark Pink.
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 98.5 mm diameter x 30 mm depth, and the color type is Pink.
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 98.5 mm diameter x 30 mm depth, and the color type is Light Pink.
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 109 mm diameter x 30 mm depth, and coler type is Dark Pink.
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 109 mm diameter x 30 mm depth, and coler type is Pink
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 109 mm diameter x 30 mm depth, and color type is Light Pink.
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Dark Pink.
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Pink.
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Light Pink.
2016-11-07
Coating Material - Coating Material is a light-cured denture base coating that is composed of two liquids that are mixed prior to use, and then photo-polymerized by a UV light. The coated surface provides smoothness and glossiness to the surface of an acrylic denture base. The coated layer is transparent, so it does not affect the original color of the denture.
2016-11-09
Sun Medical Inc - Smoke Evacuator Circuit
2017-01-23
Sun Medical Inc - Smoke Evacuator Circiut
2017-01-23
Sun Medical Inc - Smoke/Fluid evacuator system
2017-01-23
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cy
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cy
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cy
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cy
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cy
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cy
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is
2016-11-07
Acrylic Block - Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is
2016-11-07