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Keystone Dental Inc.

Last updated September 17, 2026

Information

Country: US
Address: 13645 Alton Pkwy Ste A, Irvine, CA, 92618
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3011936113
DUNS Number: —

Catalogue (2088)

Page 34 of 42

Device	Model / Reference	Registries	Class	Status
Prima	ISS1102K	FDA UDI	Class I	Active
Z-Max	CS-Z-MAX-7/8/9	FDA UDI	Class II	Unknown
Restore Implant System	RS3315-UK	FDA UDI	Class II	Active
Prima	15748K	FDA UDI	Class II	Active
Genesis	G21274	FDA UDI	Class I	Active
Restore	R9086-40-04K	FDA UDI	Class II	Active
Genesis	G21295	FDA UDI	Class I	Active
Oct	TT2	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA23018	FDA UDI	Class II	Active
Prima	L1404-01K	FDA UDI	Class II	Active
Tri-Nex Implant System	IA43-12D-10	FDA UDI	Class II	Unknown
Genesis Implant System	G21137	FDA UDI	Class II	Active
Ex Hex Implant System	ZYG-55-35N	FDA UDI	Class II	Unknown
Genesis	G21013	FDA UDI	Class I	Active
Prima	45320K	FDA UDI	Class II	Active
Genesis	G71439	FDA UDI	Class II	Active
Ex Hex Implant System	BAT 12D-13	FDA UDI	Class II	Unknown
Prima Plus	15752K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71595	FDA UDI	Class II	Active
Genesis ACTIVE	GA71568	FDA UDI	Class I	Active
Prima	15216K	FDA UDI	Class I	Active
Genesis	G21111	FDA UDI	Class II	Active
Stage 1	42026K	FDA UDI	Class II	Active
Genesis	G71438	FDA UDI	Class II	Active
Restore	R9291-34-04K	FDA UDI	Class II	Active
Prima	45067K	FDA UDI	Class II	Active
Genesis	G21100	FDA UDI	Class II	Active
Tri-Nex Implant System	TRI-MAX8-9	FDA UDI	Class II	Unknown
Genesis	G71148	FDA UDI	Class II	Active
Prima	15283K	FDA UDI	Class I	Active
Tri-Nex	HA-L-50W-5	FDA UDI	Class II	Unknown
Max	15869K	FDA UDI	Class II	Active
Genesis Implant System	G21133	FDA UDI	Class II	Active
Prima	45252K	FDA UDI	Class II	Active
Prima Plus	15757K	FDA UDI	Class I	Active
Prima	45104K	FDA UDI	Class II	Active
Restore Implant System	RS4010K	FDA UDI	Class II	Active
Oct Implant System	ITC414	FDA UDI	Class II	Unknown
Restore	L1504-50-15K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71026	FDA UDI	Class II	Active
Restore	L1101-28-15K	FDA UDI	Class I	Active
Genesis ACTIVE	GA23020	FDA UDI	Class II	Active
Restore	L1200-34-15K	FDA UDI	Class I	Active
Ex Hex Implant System	MAX-8-11	FDA UDI	Class II	Unknown
Prima	45031K	FDA UDI	Class II	Active
Tri-Nex Implant System	IA-LH-50-11.5	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSW5508-2K	FDA UDI	Class II	Active
Genesis	G71465	FDA UDI	Class II	Active
Prima	45941K	FDA UDI	Class II	Active
Prima	45440K	FDA UDI	Class II	Active

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FDA Recalls (16)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 22, 2019	Z-1061-2019	—	terminated	Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
Feb 22, 2019	Z-1062-2019	—	terminated	Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
Feb 22, 2019	Z-1063-2019	—	terminated	Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
Feb 22, 2019	Z-1064-2019	—	terminated	Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
May 1, 2018	Z-2162-2018	—	terminated	The implants are mislabeled.
Mar 13, 2018	Z-1485-2018	—	terminated	The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
Jan 24, 2018	Z-1443-2018	—	terminated	The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
Oct 16, 2017	Z-1179-2018	—	terminated	A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.
Aug 25, 2017	Z-0727-2018	—	terminated	The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.
Jun 20, 2017	Z-0608-2018	—	terminated	Abutments are unable to accept the final abutment screw
Jun 16, 2017	Z-0718-2018	—	terminated	An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Mar 9, 2017	Z-1818-2017	—	terminated	Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
Sep 15, 2016	Z-0299-2017	—	terminated	Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Mar 11, 2013	Z-0973-2013	—	terminated	Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
Jul 5, 2011	Z-0923-2013	—	terminated	Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
Jul 5, 2011	Z-0924-2013	—	terminated	Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment