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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 29 of 42

Device	Model / Reference	Registries	Class	Status
Prima	45288K	FDA UDI	Class II	Active
Stage 1	42014K	FDA UDI	Class II	Active
Renova	43102K	FDA UDI	Class II	Unknown
Genesis ACTIVE	G15108	FDA UDI	Class I	Active
Prima	45438K	FDA UDI	Class II	Active
Prima	15662K	FDA UDI	Class I	Active
Prima	15745K	FDA UDI	Class II	Active
ExHex	DBBB2	FDA UDI	Class II	Unknown
Prima	45441K	FDA UDI	Class II	Active
Prima Implant System	15424K	FDA UDI	Class II	Active
Genesis	G71545	FDA UDI	Class I	Active
Restore	R9203-50-62K	FDA UDI	Class II	Active
Tri-Nex	TCA-EL-35	FDA UDI	Class II	Unknown
Prima	45045K	FDA UDI	Class I	Active
Genesis ACTIVE	GA23010	FDA UDI	Class II	Active
Z-Max Implant System	Z-MAX7-7	FDA UDI	Class II	Unknown
Ex Hex Implant System	BAT 6	FDA UDI	Class II	Unknown
Prima	45808K	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71546	FDA UDI	Class II	Active
Prima	45311K	FDA UDI	Class I	Active
Prima Plus	15754K	FDA UDI	Class I	Active
Prima	45040K	FDA UDI	Class II	Active
Restore	R9213-55-01K	FDA UDI	Class II	Active
Prima	001-0946-00	FDA UDI	Class II	Active
Stage 1 Implant System	RSR4812-3K	FDA UDI	Class II	Active
Stage 1	S1800-45K	FDA UDI	Class II	Active
Prima	45942K	FDA UDI	Class II	Active
Genesis	G31014	FDA UDI	Class I	Active
Prima	45079K	FDA UDI	Class II	Active
Restore	L1104-16-15K	FDA UDI	Class I	Active
Stage-1	S1500-33-16K	FDA UDI	Class I	Active
Stage-1	S2426-13K	FDA UDI	Class I	Active
Stage 1	S2407-00K	FDA UDI	Class II	Active
Prima	15747K	FDA UDI	Class II	Active
Prima	45278K	FDA UDI	Class II	Active
Genesis	G71133	FDA UDI	Class II	Active
Prima	15288K	FDA UDI	Class I	Active
Prima	15201K	FDA UDI	Class I	Active
Tri-Nex	PA-NL-50	FDA UDI	Class II	Unknown
Prima Implant System	15421K	FDA UDI	Class II	Active
Genesis	G71137	FDA UDI	Class II	Active
Restore	R9650-40-02K	FDA UDI	Class II	Active
DynaGraft D	10.110.1070	FDA UDI	Class II	Active
Prima	15306K	FDA UDI	Class II	Active
Prima	45260K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71637	FDA UDI	Class I	Active
Genesis ACTIVE	GA71556	FDA UDI	Class II	Active
Restore	L1408-42K	FDA UDI	Class I	Active
PrimaSolo	15235K	FDA UDI	Class I	Active
Restore	R9210-40-02K	FDA UDI	Class II	Active

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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