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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 20 of 42

Device	Model / Reference	Registries	Class	Status
Genesis	G71144	FDA UDI	Class II	Active
Genesis ACTIVE	GA71605	FDA UDI	Class I	Active
Stage 1	S2439K	FDA UDI	Class II	Active
Z-Max	HA-Z-MAX6-3	FDA UDI	Class II	Unknown
Prima	45318K	FDA UDI	Class II	Active
Ex Hex Implant System	BBBT 15	FDA UDI	Class II	Unknown
Restore	L1804-01K	FDA UDI	Class I	Active
Prima	15076K	FDA UDI	Class I	Active
Max	45963K	FDA UDI	Class II	Active
Restore	L1100-20-20K	FDA UDI	Class I	Active
Genesis ACTIVE	GA23019	FDA UDI	Class II	Active
Ex Hex Implant System	ZYG-55-52.5N	FDA UDI	Class II	Unknown
Restore Implant System	RS3813K	FDA UDI	Class II	Active
Genesis	G71464	FDA UDI	Class II	Active
Prima	45258K	FDA UDI	Class II	Active
Oct Implant System	ITST12D-510	FDA UDI	Class II	Unknown
Tri-Nex	PA-L-18G	FDA UDI	Class II	Unknown
Stage-1	S1101-48-16K	FDA UDI	Class I	Active
Genesis	G71131	FDA UDI	Class II	Active
Genesis	G31038	FDA UDI	Class I	Active
Prima	15068K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71594	FDA UDI	Class I	Active
Restore	L1104-33-10K	FDA UDI	Class I	Active
Prima	45119K	FDA UDI	Class II	Active
Prima	45038K	FDA UDI	Class II	Active
Prima	45331K	FDA UDI	Class II	Active
Genesis ACTIVE	GA23001	FDA UDI	Class II	Active
Restore	R9295-40-02K	FDA UDI	Class II	Active
Restore	L2508-60-00K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71662	FDA UDI	Class I	Active
Genesis ACTIVE	GA71537	FDA UDI	Class II	Active
Prima	45286K	FDA UDI	Class II	Active
Prima	15740K	FDA UDI	Class II	Active
ExHex	GSU3	FDA UDI	Class II	Unknown
Prima	15280K	FDA UDI	Class I	Active
Max	15882K	FDA UDI	Class II	Active
Prima	15255K	FDA UDI	Class I	Active
Restore	L1806-03K	FDA UDI	Class I	Active
Ex Hex Implant System	ZYG-55-40N	FDA UDI	Class II	Unknown
Ex Hex Implant System	BAT 15	FDA UDI	Class II	Unknown
Prima	15224K	FDA UDI	Class I	Active
Prima	45429K	FDA UDI	Class II	Active
Prima	45150K	FDA UDI	Class II	Active
Max	45342K	FDA UDI	Class II	Active
Stage-1	S1500-55-10K	FDA UDI	Class I	Active
Prima Implant System	15426K	FDA UDI	Class II	Active
ExHex	SBA-17-TT	FDA UDI	Class II	Unknown
Prima Implant System	15425K	FDA UDI	Class II	Active
Stage 1 Implant System	RSW5508-3K	FDA UDI	Class II	Active
ExHex	AMC3	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