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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 5 of 42

Device	Model / Reference	Registries	Class	Status
Genesis	45813K	FDA UDI	Class II	Active
Max	45356K	FDA UDI	Class II	Active
Prima	15790K	FDA UDI	Class II	Active
Tri-Nex	TC-EL-60-1	FDA UDI	Class II	Unknown
Max	45354K	FDA UDI	Class II	Active
Zest	45273K	FDA UDI	Class I	Active
Genesis ACTIVE	GA23012	FDA UDI	Class II	Active
Prima	45303K	FDA UDI	Class II	Active
Stage-1	S1501-48-16K	FDA UDI	Class I	Active
Prima	15236K	FDA UDI	Class I	Active
Prima	15317K	FDA UDI	Class II	Active
Prima	15279K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71578	FDA UDI	Class II	Active
ExHex	GC-NX-50	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71548	FDA UDI	Class II	Active
ExHex	DBS24	FDA UDI	Class II	Unknown
Prima Implant System	15434K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71555	FDA UDI	Class II	Active
Prima	45052K	FDA UDI	Class II	Active
Prima	45321K	FDA UDI	Class II	Active
Max	45964K	FDA UDI	Class I	Active
ExHex	WBA6	FDA UDI	Class II	Unknown
Prima	45077K	FDA UDI	Class II	Active
Genesis Implant System	G21145	FDA UDI	Class II	Active
Prima	45152K	FDA UDI	Class II	Active
Prima Implant System	15429K	FDA UDI	Class II	Active
Genesis Implant System	G21135	FDA UDI	Class II	Active
Genesis	G21277	FDA UDI	Class I	Active
Genesis	G31041	FDA UDI	Class I	Active
ExHex	GC-NX-34	FDA UDI	Class II	Unknown
Renova	43007K	FDA UDI	Class II	Unknown
Prima	45003K	FDA UDI	Class II	Active
Renova Implant System	13004K	FDA UDI	Class II	Unknown
Oct Implant System	ITC510	FDA UDI	Class II	Unknown
Genesis ACTIVE	G15107	FDA UDI	Class I	Active
Stage-1	S2420-1K	FDA UDI	Class I	Active
DynaBlast	10.220.1030	FDA UDI	Class II	Active
Restore	L1100-30-20K	FDA UDI	Class I	Active
Genesis ACTIVE	GA22016	FDA UDI	Class II	Active
Prima Plus	15763K	FDA UDI	Class I	Active
Restore	R9660-40-04K	FDA UDI	Class II	Active
ExHex	SBBB16	FDA UDI	Class II	Unknown
Stage-1	S1101-42-10K	FDA UDI	Class I	Active
Prima	45817K	FDA UDI	Class II	Unknown
Oct	TSAF4	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSR4116-2K	FDA UDI	Class II	Active
Stage 1 Implant System	RSR3314-3K	FDA UDI	Class II	Active
Genesis	G71236	FDA UDI	Class II	Active
Restore	I3280-40K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71015	FDA UDI	Class II	Active

Related Companies

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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