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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 18 of 42

Device	Model / Reference	Registries	Class	Status
ExHex	WBN6	FDA UDI	Class II	Unknown
Prima	45437K	FDA UDI	Class II	Active
Prima	45114K	FDA UDI	Class II	Active
Prima	45033K	FDA UDI	Class II	Active
Genesis	G31002	FDA UDI	Class I	Active
Restore	L9105-1K	FDA UDI	Class I	Active
Prima	45032K	FDA UDI	Class II	Active
Prima Implant System	15410K	FDA UDI	Class II	Active
Max	15867K	FDA UDI	Class II	Active
Restore	L1502-40-13K	FDA UDI	Class I	Active
Prima	15676K	FDA UDI	Class I	Active
ExHex	SCU6	FDA UDI	Class II	Unknown
Genesis ACTIVE	G15110	FDA UDI	Class I	Active
Restore	41006K	FDA UDI	Class II	Active
Oct Implant System	ITC410	FDA UDI	Class II	Unknown
Restore	L1400-62-23K	FDA UDI	Class I	Active
Prima Plus	15784K	FDA UDI	Class I	Active
Renova Implant System	13002K	FDA UDI	Class II	Unknown
Tri-Nex	MC-L-43-4	FDA UDI	Class II	Unknown
Prima	45940K	FDA UDI	Class II	Active
Prima	45806K	FDA UDI	Class II	Unknown
ExHex	AMC1	FDA UDI	Class II	Unknown
Prima	45065K	FDA UDI	Class II	Active
Stage 1	S2405-01K	FDA UDI	Class II	Active
Genesis ACTIVE	GA21005	FDA UDI	Class II	Active
Prima Implant System	15427K	FDA UDI	Class II	Active
ExHex	TSHZ2	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71070	FDA UDI	Class II	Active
Genesis	G21101	FDA UDI	Class II	Active
Genesis ACTIVE	GA71107	FDA UDI	Class I	Active
Prima	45933K	FDA UDI	Class II	Active
Ex Hex Implant System	BAT 13	FDA UDI	Class II	Unknown
Ex Hex Implant System	BBBS 8.5	FDA UDI	Class II	Unknown
Tri-Nex	PA-NL-35	FDA UDI	Class II	Unknown
Restore	L9102-1	FDA UDI	Class I	Active
Oct Implant System	ITT414	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSR4108-2K	FDA UDI	Class II	Active
Prima	15289K	FDA UDI	Class I	Active
Genesis ACTIVE	G15118	FDA UDI	Class I	Active
Prima Implant System	15400K	FDA UDI	Class II	Active
Stage-1	S1500-55-16K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71631	FDA UDI	Class II	Active
Tri-Nex Implant System	IA-LH-35-8	FDA UDI	Class II	Unknown
ExHex	TSH3	FDA UDI	Class II	Unknown
Genesis	G71610	FDA UDI	Class I	Active
Prima	45080K	FDA UDI	Class II	Active
Restore Implant System	RS4015K	FDA UDI	Class II	Active
Stage-1	S1101-28-10K	FDA UDI	Class I	Active
Restore Implant System	11008K	FDA UDI	Class II	Active
Prima Implant System	15412K	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