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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 16 of 42

Device	Model / Reference	Registries	Class	Status
Stage-1	S1803-35K	FDA UDI	Class I	Active
Restore	R9192-33-05K	FDA UDI	Class I	Active
Genesis	G71436	FDA UDI	Class II	Active
ExHex	DB2	FDA UDI	Class II	Unknown
Genesis	G31031	FDA UDI	Class I	Active
Restore	R9192-40-05K	FDA UDI	Class I	Active
Ex Hex Implant System	BBBT 10	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71543	FDA UDI	Class II	Active
Genesis ACTIVE	G15145	FDA UDI	Class I	Active
Genesis ACTIVE	GA71047	FDA UDI	Class II	Active
Genesis ACTIVE	GA71632	FDA UDI	Class II	Active
Max	45337K	FDA UDI	Class II	Active
Stage 1	42018K	FDA UDI	Class II	Active
Tri-Nex	MC-L-50-3	FDA UDI	Class II	Unknown
Prima	45282K	FDA UDI	Class II	Active
Restore	R9290-34-02K	FDA UDI	Class II	Active
Prima Implant System	15632K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71500	FDA UDI	Class I	Active
Renova	43118K	FDA UDI	Class II	Unknown
Prima	15253K	FDA UDI	Class I	Active
Restore	L1400-85-23K	FDA UDI	Class I	Active
Tri-Nex Implant System	IA-LH-43-10	FDA UDI	Class II	Unknown
Prima	45428K	FDA UDI	Class II	Active
Restore Implant System	11003K	FDA UDI	Class II	Active
Ex Hex Implant System	BAT 12D-10	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71586	FDA UDI	Class II	Active
Ex Hex Implant System	IBN 13	FDA UDI	Class II	Unknown
Ex Hex Implant System	BA 8.5	FDA UDI	Class II	Unknown
Ex Hex Implant System	IBS 13	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA21019	FDA UDI	Class II	Active
Prima	45283K	FDA UDI	Class II	Active
Oct Implant System	ITT408	FDA UDI	Class II	Unknown
ExHex	GC-NX-60	FDA UDI	Class II	Unknown
Restore	ISS185TK	FDA UDI	Class I	Active
Restore	410240-42-02K	FDA UDI	Class II	Active
Stage-1	S1100-42-10K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71530	FDA UDI	Class I	Active
Tri-Nex	MCN-L-50-3	FDA UDI	Class II	Unknown
Prima	45064K	FDA UDI	Class II	Active
Tri-Nex	PA-L-20G	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71527	FDA UDI	Class I	Active
Restore Implant System	TS3311K	FDA UDI	Class II	Active
Stage-1	S1501-41-10K	FDA UDI	Class I	Active
Prima	45276K	FDA UDI	Class II	Active
Prima	45007K	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71638	FDA UDI	Class I	Active
Genesis ACTIVE	GA31003	FDA UDI	Class I	Active
Prima	15260K	FDA UDI	Class I	Active
Restore	L1806-05K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71037	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