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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 4 of 42

Device	Model / Reference	Registries	Class	Status
Prima	15261K	FDA UDI	Class I	Active
Prima Implant System	15423K	FDA UDI	Class II	Active
Restore Implant System	RS5010-UK	FDA UDI	Class II	Active
Tri-Nex	PA-EL-43	FDA UDI	Class II	Unknown
Restore Implant System	RS3808K	FDA UDI	Class II	Active
Restore	R9290-50-02K	FDA UDI	Class II	Active
ExHex	SBA16	FDA UDI	Class II	Unknown
Stage 1	42011K	FDA UDI	Class II	Active
Prima	15200K	FDA UDI	Class I	Active
Ex Hex Implant System	BAT 8.5	FDA UDI	Class II	Unknown
Genesis ACTIVE	G15146	FDA UDI	Class I	Active
Restore	L1104-42-10K	FDA UDI	Class I	Active
Prima Implant System	15631K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71559	FDA UDI	Class II	Active
Stage 1 Implant System	RSR4112-2K	FDA UDI	Class II	Active
Prima	15778K	FDA UDI	Class I	Active
Tri-Nex	GC-EL-43	FDA UDI	Class II	Unknown
Prima	45816K	FDA UDI	Class II	Unknown
Prima Plus	15776K	FDA UDI	Class I	Active
Stage 1	S2408K	FDA UDI	Class II	Active
Tri-Nex	MC-L-43-5	FDA UDI	Class II	Unknown
Max	45339K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71010	FDA UDI	Class I	Active
Oct	P-CAP6-40	FDA UDI	Class II	Unknown
Restore	L1504-40-18K	FDA UDI	Class I	Active
Stage-1	S1400-01K	FDA UDI	Class I	Active
Sustain	410240-34-02K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71610	FDA UDI	Class II	Active
Prima	45937K	FDA UDI	Class II	Active
Prima Implant System	15435K	FDA UDI	Class II	Active
Prima	15273K	FDA UDI	Class I	Active
Restore	L2100-96-19K	FDA UDI	Class I	Active
Genesis	G71204	FDA UDI	Class II	Active
Prima Implant System	15620K	FDA UDI	Class II	Active
Prima	15214K	FDA UDI	Class I	Active
Ex Hex Implant System	BBBT 12D-15	FDA UDI	Class II	Unknown
Prima	15315K	FDA UDI	Class II	Active
Restore Implant System	TS4008K	FDA UDI	Class II	Active
Tri-Nex	PA-MC-14-S	FDA UDI	Class II	Unknown
DynaGraft D	10.120.1050	FDA UDI	Class II	Active
Renova	10040K	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71598	FDA UDI	Class I	Active
Prima	15737K	FDA UDI	Class II	Active
Restore	R9203-40-48K	FDA UDI	Class II	Active
Genesis ACTIVE	GA23002	FDA UDI	Class II	Active
Prima Plus	15760K	FDA UDI	Class I	Active
Prima Implant System	15706K	FDA UDI	Class II	Active
Prima	45054K	FDA UDI	Class II	Active
Prima	45279K	FDA UDI	Class II	Active
Restore	R9633-34-06K	FDA UDI	Class II	Active

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Importers

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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