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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 17 of 42

Device	Model / Reference	Registries	Class	Status
Stage 1 Implant System	RSR4808-2K	FDA UDI	Class II	Active
Genesis	G71434	FDA UDI	Class II	Active
ExHex	GSQZ2	FDA UDI	Class II	Unknown
Max	15872K	FDA UDI	Class II	Active
Prima	15791K	FDA UDI	Class II	Active
Ex Hex Implant System	IBN 18	FDA UDI	Class II	Unknown
Restore	R9285-40K	FDA UDI	Class II	Active
Genesis	G71212	FDA UDI	Class II	Active
Prima Plus	15764K	FDA UDI	Class I	Active
Genesis ACTIVE	GA23015	FDA UDI	Class II	Active
Restore	L2300-33-02K	FDA UDI	Class II	Active
Stage 1	S2504K	FDA UDI	Class II	Active
Tri-Nex	TS-L-18	FDA UDI	Class II	Unknown
Stage-1	S1101-42-16K	FDA UDI	Class I	Active
Genesis	G31029	FDA UDI	Class I	Active
Restore	R9655-34-06K	FDA UDI	Class II	Active
Prima	45056K	FDA UDI	Class II	Active
Ex Hex Implant System	IBT 12D-13	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA21014	FDA UDI	Class II	Active
Prima	45244K	FDA UDI	Class II	Active
Oct	TT6-6	FDA UDI	Class II	Unknown
Prima Implant System	15626K	FDA UDI	Class II	Active
Genesis ACTIVE	GA22003	FDA UDI	Class II	Active
Prima	15733K	FDA UDI	Class II	Active
Ex Hex Implant System	MAX-9-11	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71535	FDA UDI	Class II	Active
ExHex	AMCZ1	FDA UDI	Class II	Unknown
Genesis	G71449	FDA UDI	Class II	Active
Genesis ACTIVE	GA23003	FDA UDI	Class II	Active
ExHex	TBA2	FDA UDI	Class II	Unknown
Restore	L9102-1K	FDA UDI	Class I	Active
Prima	45423K	FDA UDI	Class II	Active
Tri-Nex	HA-L-43-7	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71606	FDA UDI	Class II	Active
Prima Implant System	15623K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71661	FDA UDI	Class I	Active
Restore Implant System	11006K	FDA UDI	Class II	Active
Prima Implant System	15621K	FDA UDI	Class II	Active
Max	15868K	FDA UDI	Class II	Active
Stage 1	S2501-55-1K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71596	FDA UDI	Class II	Active
Oct Implant System	ITT610	FDA UDI	Class II	Unknown
Renova	10032K	FDA UDI	Class II	Unknown
Genesis	G71132	FDA UDI	Class II	Active
Restore	L1104-52-10K	FDA UDI	Class I	Active
Restore	R9633-40-02K	FDA UDI	Class II	Active
Renova Implant System	14003K	FDA UDI	Class II	Unknown
ExHex	GSIT2	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71599	FDA UDI	Class II	Active
Stage-1	S1100-16-10K	FDA UDI	Class I	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