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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 19 of 42

Device	Model / Reference	Registries	Class	Status
Renova Implant System	14007K	FDA UDI	Class II	Unknown
Prima	15070K	FDA UDI	Class I	Active
Genesis	G71531	FDA UDI	Class II	Active
Genesis	G71450	FDA UDI	Class II	Active
Z-Max	HA-Z-MAX6-6	FDA UDI	Class II	Unknown
Restore	L1502-38-13K	FDA UDI	Class I	Active
Z-Max Implant System	Z-MAX7-9	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71593	FDA UDI	Class I	Active
Genesis	G71512	FDA UDI	Class II	Active
Genesis ACTIVE	GA71576	FDA UDI	Class II	Active
Prima	45294K	FDA UDI	Class I	Active
ExHex	WB2	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71063	FDA UDI	Class II	Active
Genesis	G21012	FDA UDI	Class I	Active
ExHex	WB4	FDA UDI	Class II	Unknown
Stage-1	S2418-19-1K	FDA UDI	Class I	Active
Prima	15221K	FDA UDI	Class II	Active
Genesis	G71130	FDA UDI	Class II	Active
Genesis ACTIVE	GA71035	FDA UDI	Class II	Active
Prima	15301K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71204	FDA UDI	Class I	Active
Genesis	G71611	FDA UDI	Class I	Active
Genesis ACTIVE	GA71032	FDA UDI	Class II	Active
Prima	45285K	FDA UDI	Class II	Active
Prima	15667K	FDA UDI	Class I	Active
Genesis	G71539	FDA UDI	Class II	Active
Prima Implant System	15407K	FDA UDI	Class II	Active
Prima	15674K	FDA UDI	Class I	Active
Tri-Nex	GS-L-20	FDA UDI	Class II	Unknown
Genesis	G71462	FDA UDI	Class II	Active
Restore Implant System	TS3815K	FDA UDI	Class II	Active
Stage-1	S1701-03K	FDA UDI	Class I	Active
Restore Implant System	TS3311-UK	FDA UDI	Class II	Active
Restore	R2302-42-02K	FDA UDI	Class II	Active
Ex Hex Implant System	ZYG-55-45N	FDA UDI	Class II	Unknown
Restore Implant System	RS4006K	FDA UDI	Class II	Active
Prima	45151K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71608	FDA UDI	Class II	Active
Prima	45251K	FDA UDI	Class II	Active
Prima	15215K	FDA UDI	Class I	Active
Prima	15067K	FDA UDI	Class I	Active
Restore Implant System	TS4010K	FDA UDI	Class II	Active
Prima	15309K	FDA UDI	Class II	Active
Prima	45118K	FDA UDI	Class II	Active
Prima Implant System	15634K	FDA UDI	Class II	Active
Restore	L1400-48-28K	FDA UDI	Class I	Active
Stage-1	S9100-1K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71600	FDA UDI	Class II	Active
Stage-1	ISS140K	FDA UDI	Class I	Active
Prima Implant System	15713K	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