Is this your brand? Sign in to claim ownership.

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 23 of 42

Device	Model / Reference	Registries	Class	Status
Prima	45046K	FDA UDI	Class II	Active
ExHex	TCMAX9-1NH	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSW5514-2K	FDA UDI	Class II	Active
Ex Hex Implant System	IBN 8.5	FDA UDI	Class II	Unknown
Prima	15264K	FDA UDI	Class I	Active
Genesis ACTIVE	GA71573	FDA UDI	Class II	Active
Prima	45117K	FDA UDI	Class II	Active
Prima	15073K	FDA UDI	Class I	Active
Restore	L2500-60-00K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71109	FDA UDI	Class I	Active
Stage 1	S2417-0K	FDA UDI	Class II	Active
Restore	41004K	FDA UDI	Class II	Active
Genesis	G71203	FDA UDI	Class II	Active
Tri-Nex	MC-L-43-1	FDA UDI	Class II	Unknown
Tri-Nex	HA-L-43W-5	FDA UDI	Class II	Unknown
Prima	45317K	FDA UDI	Class II	Active
Prima	45051K	FDA UDI	Class II	Active
Restore Implant System	11013K	FDA UDI	Class II	Active
Stage-1	S1400-02K	FDA UDI	Class I	Active
Tri-Nex	TMC1	FDA UDI	Class II	Unknown
ExHex	SCAU5	FDA UDI	Class II	Unknown
Prima	15661K	FDA UDI	Class I	Active
ExHex	EPC-TN-50-2KT	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71629	FDA UDI	Class II	Active
Restore	RS3806K	FDA UDI	Class II	Active
Restore	L1709-01K	FDA UDI	Class I	Active
Prima	15219K	FDA UDI	Class I	Active
Prima	45439K	FDA UDI	Class II	Active
Stage-1	S1801-01K	FDA UDI	Class I	Active
ExHex	GC-EX-34	FDA UDI	Class II	Unknown
Tri-Nex Implant System	TRI-MAX7-7	FDA UDI	Class II	Unknown
Genesis	G71446	FDA UDI	Class II	Active
Genesis Implant System	G21132	FDA UDI	Class II	Active
Genesis Implant System	G21051	FDA UDI	Class II	Unknown
Restore	R9292-40-04K	FDA UDI	Class II	Active
Stage 1 Implant System	RSR4814-3K	FDA UDI	Class II	Active
Prima	45312K	FDA UDI	Class II	Active
Restore	R9302-40-48K	FDA UDI	Class II	Active
Prima	45116K	FDA UDI	Class II	Active
Prima Implant System	15415K	FDA UDI	Class II	Active
Restore	L1502-38-18K	FDA UDI	Class I	Active
Prima	45101K	FDA UDI	Class II	Active
ExHex	WBA3	FDA UDI	Class II	Unknown
Prima	45070K	FDA UDI	Class II	Active
Prima	45420K	FDA UDI	Class II	Active
Genesis	G71217	FDA UDI	Class II	Active
Restore	L9104-1K	FDA UDI	Class I	Active
Prima	45316K	FDA UDI	Class II	Active
Restore	L1406-01K	FDA UDI	Class I	Active
Prima	45315K	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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