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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 22 of 42

Device	Model / Reference	Registries	Class	Status
Restore	L1101-33-15K	FDA UDI	Class I	Active
Prima	45009K	FDA UDI	Class II	Unknown
Prima	45333K	FDA UDI	Class II	Active
Prima	15281K	FDA UDI	Class I	Active
Prima	45112K	FDA UDI	Class II	Active
Prima	45426K	FDA UDI	Class II	Active
Prima	15655K	FDA UDI	Class I	Active
Prima	15735K	FDA UDI	Class II	Active
Prima	45042K	FDA UDI	Class II	Active
Genesis	G31046	FDA UDI	Class I	Active
Prima	45325K	FDA UDI	Class II	Active
Prima	45049K	FDA UDI	Class II	Active
Prima Implant System	15630K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71065	FDA UDI	Class II	Active
Genesis ACTIVE	G15104	FDA UDI	Class I	Active
Renova	43110K	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71022	FDA UDI	Class II	Active
Genesis	G71510	FDA UDI	Class II	Active
Prima Plus	15758K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71039	FDA UDI	Class II	Active
Genesis	G71136	FDA UDI	Class II	Active
Prima	15669K	FDA UDI	Class I	Active
Genesis	G71231	FDA UDI	Class II	Active
Restore	R9660-40-02K	FDA UDI	Class II	Active
Stage 1 Implant System	RSW5512-2K	FDA UDI	Class II	Active
Stage 1	S2407-01K	FDA UDI	Class II	Active
Prima	15314K	FDA UDI	Class II	Active
Prima Implant System	15422K	FDA UDI	Class II	Active
Prima	15206K	FDA UDI	Class I	Active
Prima	15205K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71017	FDA UDI	Class II	Active
Oct	TSA6-4	FDA UDI	Class II	Unknown
Oct Implant System	ITC314	FDA UDI	Class II	Unknown
DynaGraft D	10.120.1070	FDA UDI	Class II	Active
Genesis	G39999	FDA UDI	Class I	Active
Genesis	G21278	FDA UDI	Class I	Active
Oct Implant System	ITST12D-514	FDA UDI	Class II	Unknown
Max	15866K	FDA UDI	Class II	Active
Restore Implant System	11007K	FDA UDI	Class II	Active
Restore Implant System	RS4010-UK	FDA UDI	Class II	Active
Max	15864K	FDA UDI	Class II	Active
Ex Hex Implant System	BBBS 13	FDA UDI	Class II	Unknown
Prima	15204K	FDA UDI	Class I	Active
Genesis Implant System	G21152	FDA UDI	Class II	Active
Genesis	G31034	FDA UDI	Class I	Active
Prima	15203K	FDA UDI	Class I	Active
Restore	ISS1118-1K	FDA UDI	Class I	Active
Stage-1	S1100-48-10K	FDA UDI	Class I	Active
Ex Hex Implant System	IBN 10	FDA UDI	Class II	Unknown
ExHex	DBA5	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