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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 21 of 42

Device	Model / Reference	Registries	Class	Status
Stage 1 Implant System	RSR4114-2K	FDA UDI	Class II	Active
Prima	45936K	FDA UDI	Class II	Active
Genesis	G21294	FDA UDI	Class I	Active
Prima	15746K	FDA UDI	Class II	Active
Stage 1	S1800-30K	FDA UDI	Class II	Active
Prima	15313K	FDA UDI	Class II	Active
Tri-Nex	HA-L-50-3	FDA UDI	Class II	Unknown
Prima	15739K	FDA UDI	Class II	Active
ExHex	TB9MAX-5.5	FDA UDI	Class II	Unknown
Prima	15310K	FDA UDI	Class II	Active
Prima	15682K	FDA UDI	Class II	Active
Ex Hex Implant System	IBT 18	FDA UDI	Class II	Unknown
Genesis	G31026	FDA UDI	Class I	Active
Prima Plus	15762K	FDA UDI	Class I	Active
Genesis	G71441	FDA UDI	Class II	Active
Restore	L2700-50-01K	FDA UDI	Class II	Active
ExHex	HMCTW9-6	FDA UDI	Class II	Unknown
ExHex	TB6	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA31000	FDA UDI	Class I	Active
Genesis	G21109	FDA UDI	Class II	Active
Oct Implant System	ITT608	FDA UDI	Class II	Unknown
Restore Implant System	TS4013-UK	FDA UDI	Class II	Active
DynaGraft D	10.120.1060	FDA UDI	Class II	Active
ExHex	TB4	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSW4812-2K	FDA UDI	Class II	Active
Genesis	G71209	FDA UDI	Class II	Active
Restore	L1414-01K	FDA UDI	Class I	Active
Tri-Nex	GC-NL-60	FDA UDI	Class II	Unknown
Prima	15652K	FDA UDI	Class I	Active
Restore	L1104-42-15K	FDA UDI	Class I	Active
Genesis	G71213	FDA UDI	Class II	Active
Prima Implant System	15409K	FDA UDI	Class II	Active
Genesis	G31016	FDA UDI	Class I	Active
Genesis ACTIVE	GA22013	FDA UDI	Class II	Active
Genesis ACTIVE	GA71552	FDA UDI	Class II	Active
Genesis	G31000	FDA UDI	Class I	Active
Genesis Implant System	G21131	FDA UDI	Class II	Active
Restore	R9287-40-01K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71640	FDA UDI	Class II	Active
Restore Implant System	RS4015-UK	FDA UDI	Class II	Active
Restore	L1703-01K	FDA UDI	Class II	Active
Tri-Nex	CS-L-43	FDA UDI	Class II	Unknown
Prima	45068K	FDA UDI	Class II	Active
Tri-Nex	GC-EL-50	FDA UDI	Class II	Unknown
ExHex	GSH1	FDA UDI	Class II	Unknown
Z-Max Implant System	Z-MAX9-11	FDA UDI	Class II	Unknown
Tri-Nex Implant System	TRI-MAX7-11	FDA UDI	Class II	Unknown
Max	45335K	FDA UDI	Class II	Active
Restore Implant System	RS3308K	FDA UDI	Class II	Active
Prima	15268K	FDA UDI	Class I	Active

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Importers

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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