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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 37 of 42

Device	Model / Reference	Registries	Class	Status
Prima	15262K	FDA UDI	Class I	Active
ExHex	DBBBS12	FDA UDI	Class II	Unknown
Oct	TT6-5	FDA UDI	Class II	Unknown
Oct Implant System	ITT508	FDA UDI	Class II	Unknown
Max	45336K	FDA UDI	Class II	Active
Oct Implant System	MAXIT9-7	FDA UDI	Class II	Unknown
ExHex	ABAMC3	FDA UDI	Class II	Unknown
Prima	15213K	FDA UDI	Class I	Active
Restore	L2505-60-04K	FDA UDI	Class II	Active
ExHex	SCU2	FDA UDI	Class II	Unknown
Prima	L1407K	FDA UDI	Class I	Active
Restore	42023K	FDA UDI	Class II	Active
Tri-Nex Implant System	IA43-12D-13	FDA UDI	Class II	Unknown
Genesis ACTIVE	GA71588	FDA UDI	Class II	Active
Renova	43100K	FDA UDI	Class II	Unknown
Genesis	G31009	FDA UDI	Class I	Active
Restore	L1504-38-18K	FDA UDI	Class I	Active
Restore	L1809-40-01K	FDA UDI	Class II	Active
Prima	15286K	FDA UDI	Class I	Active
Prima	15789K	FDA UDI	Class II	Active
Stage-1	S1500-63-10K	FDA UDI	Class I	Active
Prima	45236K	FDA UDI	Class II	Active
Prima	45075K	FDA UDI	Class II	Active
Restore	L2508-60-01K	FDA UDI	Class II	Active
ExHex	HMC6	FDA UDI	Class II	Unknown
Restore Implant System	11010K	FDA UDI	Class II	Active
Genesis	G71508	FDA UDI	Class II	Active
Prima	15651K	FDA UDI	Class I	Active
Prima	45430K	FDA UDI	Class II	Active
Oct Implant System	MAXIT7-7	FDA UDI	Class II	Unknown
Prima	45053K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71049	FDA UDI	Class II	Active
Prima	15284K	FDA UDI	Class I	Active
ExHex	SCNU2	FDA UDI	Class II	Unknown
Prima	45211K	FDA UDI	Class II	Active
Prima Implant System	15405K	FDA UDI	Class II	Active
Restore	L1805-01K	FDA UDI	Class I	Active
Restore	L1810-50-01K	FDA UDI	Class II	Active
Genesis ACTIVE	GA71016	FDA UDI	Class II	Active
ExHex	TCMAX9-1H	FDA UDI	Class II	Unknown
Stage 1 Implant System	RSR3310-3K	FDA UDI	Class II	Active
Genesis ACTIVE	GA23005	FDA UDI	Class II	Active
ExHex	ABAMCZ1	FDA UDI	Class II	Unknown
Sustain	410200-33-30K	FDA UDI	Class II	Active
Restore Implant System	TS3813-UK	FDA UDI	Class II	Active
Prima Implant System	15406K	FDA UDI	Class II	Active
Genesis ACTIVE	G15102	FDA UDI	Class I	Active
Prima	15267K	FDA UDI	Class I	Active
Restore	42021K	FDA UDI	Class II	Active
Prima	15208K	FDA UDI	Class I	Active

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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