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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 28 of 42

Device	Model / Reference	Registries	Class	Status
Restore	R9301-34-48K	FDA UDI	Class II	Active
Restore Implant System	11016K	FDA UDI	Class II	Active
Genesis ACTIVE	G15148	FDA UDI	Class I	Active
Oct Implant System	ITC310	FDA UDI	Class II	Unknown
Prima	45069K	FDA UDI	Class II	Active
Ex Hex Implant System	BAT 12D-15	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA22008	FDA UDI	Class II	Active
Genesis ACTIVE	GA23009	FDA UDI	Class II	Active
Genesis ACTIVE	GA23006	FDA UDI	Class II	Active
Prima	45265K	FDA UDI	Class II	Active
Prima	45254K	FDA UDI	Class II	Active
Prima	15657K	FDA UDI	Class I	Active
Prima Implant System	15428K	FDA UDI	Class II	Active
Ex Hex Implant System	BBBT 13	FDA UDI	Class II	Unknown
Genesis Implant System	G21052	FDA UDI	Class II	Unknown
ExHex	AMCZ5	FDA UDI	Class II	Unknown
Prima	45044K	FDA UDI	Class II	Active
Prima	45043K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71627	FDA UDI	Class II	Active
Genesis ACTIVE	GA71091	FDA UDI	Class II	Active
Tri-Nex	TCA-EL-50	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSW6308-2K	FDA UDI	Class II	Active
Prima Implant System	15420K	FDA UDI	Class II	Active
Prima	15207K	FDA UDI	Class I	Active
Stage 1	S2501-40-1K	FDA UDI	Class II	Active
Restore	L1700-20K	FDA UDI	Class I	Active
Prima	15659K	FDA UDI	Class I	Active
Restore	L1700-25K	FDA UDI	Class I	Active
Prima	15248K	FDA UDI	Class I	Active
Prima Plus	15761K	FDA UDI	Class I	Active
Prima	15680K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71619	FDA UDI	Class II	Active
Prima	15274K	FDA UDI	Class I	Active
Stage 1	42019K	FDA UDI	Class II	Active
Restore Implant System	RS4013K	FDA UDI	Class II	Active
Accell Connexus	10.310.1060	FDA UDI	Class II	Active
Genesis ACTIVE	GA23008	FDA UDI	Class II	Active
Genesis ACTIVE	GA71561	FDA UDI	Class II	Active
Genesis ACTIVE	GA71534	FDA UDI	Class I	Active
Tri-Nex Implant System	IA-LH-60-11.5	FDA UDI	Class II	Unknown
Ex Hex Implant System	IBS 8.5	FDA UDI	Class II	Unknown
Restore	R9121K	FDA UDI	Class I	Active
Genesis	G21110	FDA UDI	Class II	Active
Genesis ACTIVE	GA71045	FDA UDI	Class II	Active
Stage-1	S1400-03K	FDA UDI	Class I	Active
ExHex	GSQZ3	FDA UDI	Class II	Unknown
Oct Implant System	ITC408	FDA UDI	Class II	Unknown
Genesis	G71505	FDA UDI	Class II	Active
Stage-1	S1101-20-10K	FDA UDI	Class I	Active
Oct	ITS6-TC1NE	FDA UDI	Class II	Unknown

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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