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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 3 of 42

Device	Model / Reference	Registries	Class	Status
Prima Implant System	15616K	FDA UDI	Class II	Active
Tri-Nex	PA-MC-60	FDA UDI	Class II	Unknown
Ex Hex Implant System	BA 11.5	FDA UDI	Class II	Unknown
Restore	R9136-42-10K	FDA UDI	Class I	Active
Prima Plus	15770K	FDA UDI	Class I	Active
Stage-1	S1401-33-01K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71557	FDA UDI	Class II	Active
ExHex	WBN2	FDA UDI	Class II	Unknown
Restore	L1100-42-15K	FDA UDI	Class I	Active
Prima	15069K	FDA UDI	Class I	Active
Genesis ACTIVE	GA21003	FDA UDI	Class II	Active
Genesis ACTIVE	GA71581	FDA UDI	Class II	Active
Oct	ITS6-PA-NE	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71092	FDA UDI	Class II	Active
Prima	15276K	FDA UDI	Class I	Active
Prima	45245K	FDA UDI	Class II	Active
Restore Implant System	RS6011K	FDA UDI	Class II	Active
Genesis	G31013	FDA UDI	Class I	Active
Genesis ACTIVE	GA21018	FDA UDI	Class II	Active
Stage 1 Implant System	RSW4808-3K	FDA UDI	Class II	Active
Genesis	G31037	FDA UDI	Class I	Active
Prima Implant System	15418K	FDA UDI	Class II	Active
Tri-Nex	TCA12-EL-43	FDA UDI	Class II	Unknown
Restore	R9213-40-01K	FDA UDI	Class II	Active
Stage 1	42008K	FDA UDI	Class II	Active
Oct Implant System	ITC308	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71541	FDA UDI	Class II	Active
ExHex	TSU3	FDA UDI	Class II	Unknown
Genesis	G71547	FDA UDI	Class I	Active
Prima	45210K	FDA UDI	Class II	Active
Restore	R9633-50-04K	FDA UDI	Class II	Active
Tri-Nex	CS-L-60	FDA UDI	Class II	Unknown
Genesis	G71453	FDA UDI	Class II	Active
Genesis	G71507	FDA UDI	Class II	Active
Genesis ACTIVE	GA71564	FDA UDI	Class II	Active
Z-Max Implant System	Z-MAX7-11	FDA UDI	Class II	Unknown
Restore	L1401-38-02K	FDA UDI	Class I	Active
Restore	L2800-01K	FDA UDI	Class I	Active
Stage-1	S1803-48K	FDA UDI	Class I	Active
Tri-Nex Implant System	IA-LH-43-13	FDA UDI	Class II	Unknown
Stage-1	42003K	FDA UDI	Class I	Active
Restore	L1101-30-15K	FDA UDI	Class I	Active
Oct	TSA6-5.5	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSW4814-2K	FDA UDI	Class II	Active
Oct	SYN15D-F6	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71038	FDA UDI	Class II	Active
Renova	43111K	FDA UDI	Class II	Unknown
Restore	R9192-33-15K	FDA UDI	Class I	Active
Prima Implant System	15709K	FDA UDI	Class II	Active
ExHex	GC-EX-50	FDA UDI	Class II	Unknown

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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