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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 8 of 42

Device	Model / Reference	Registries	Class	Status
Genesis ACTIVE	G15105	FDA UDI	Class I	Active
Genesis	G31015	FDA UDI	Class I	Active
Genesis	G71452	FDA UDI	Class II	Active
Genesis	G21204	FDA UDI	Class II	Active
Prima	15300K	FDA UDI	Class II	Active
Prima Implant System	15419K	FDA UDI	Class II	Active
Prima	45008K	FDA UDI	Class II	Unknown
Oct Implant System	ITST12D-508	FDA UDI	Class II	Unknown
Ex Hex Implant System	MAX-7-7	FDA UDI	Class II	Unknown
Restore Implant System	TS3813K	FDA UDI	Class II	Active
Restore	R9642-34-04K	FDA UDI	Class II	Active
Genesis ACTIVE	GA23011	FDA UDI	Class II	Active
Prima	45290K	FDA UDI	Class II	Active
Max	45360K	FDA UDI	Class II	Active
Genesis Implant System	G21151	FDA UDI	Class II	Active
Ex Hex Implant System	IBT 6	FDA UDI	Class II	Unknown
Restore Implant System	RS3811K	FDA UDI	Class II	Active
Prima	15318K	FDA UDI	Class II	Active
Genesis	G71548	FDA UDI	Class I	Active
Restore Implant System	RS5008K	FDA UDI	Class II	Active
Max	45340K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71563	FDA UDI	Class II	Active
Ex Hex Implant System	BBBS 15	FDA UDI	Class II	Unknown
Prima	15257K	FDA UDI	Class I	Active
ExHex	HMCT7-6	FDA UDI	Class II	Unknown
Prima	45301K	FDA UDI	Class II	Active
Oct Implant System	MAXIT8-11	FDA UDI	Class II	Unknown
Restore	L1100-52-10K	FDA UDI	Class I	Active
ExHex	GMC1	FDA UDI	Class II	Unknown
Restore	L1102-20-10K	FDA UDI	Class I	Active
Stage 1 Implant System	RSR3312-2K	FDA UDI	Class II	Active
ExHex	EPC-TN-60-1KT	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71031	FDA UDI	Class II	Active
ExHex	TSHZ3	FDA UDI	Class II	Unknown
Prima	15686K	FDA UDI	Class I	Active
Genesis ACTIVE	GA21010	FDA UDI	Class II	Active
Prima	15672K	FDA UDI	Class I	Active
Tri-Nex	GS-L-18	FDA UDI	Class II	Unknown
ExHex	TB9MAX-7	FDA UDI	Class II	Unknown
Prima	45071K	FDA UDI	Class II	Active
Renova	43121K	FDA UDI	Class II	Unknown
Ex Hex Implant System	BA 15	FDA UDI	Class II	Unknown
Renova	43120K	FDA UDI	Class II	Unknown
Restore Implant System	TS4011-UK	FDA UDI	Class II	Active
ExHex	EPC-TN-60-2KT	FDA UDI	Class II	Unknown
Restore Implant System	11015K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71545	FDA UDI	Class II	Active
Stage 1 Implant System	RSR4810-3K	FDA UDI	Class II	Active
Stage 1 Implant System	RSR4816-2K	FDA UDI	Class II	Active
Prima	15244K	FDA UDI	Class I	Active

Related Companies

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Importers

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Notified Bodies

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Authorities

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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