3m Espe Dental Products

FDA Filings

This page includes the latest FDA filings for 3m Espe Dental Products. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005174370
• FEI Number: 3005174370
• Name: 3M ESPE DENTAL PRODUCTS
• Owner & Operator: 3M COMPANY
• Contact Address: 3M Center, 2510 Conway Ave. Bldg. 275-5W-06; Saint Paul MN 55144 US
• Official Correspondent:
  • SUZANNE M DANIELSON
  • x-651-7334365-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2510 Conway Avenue ; Saint Paul, MN 55144 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 2020493
• FEI Number: 2020493
• Name: 3M ESPE Dental Products
• Owner & Operator: 3M COMPANY
• Contact Address: 3M Center, 2510 Conway Ave. Bldg. 275-5W-06; Saint Paul MN 55144 US
• Official Correspondent:
  • SUZANNE M DANIELSON
  • x-651-7334365-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2111 McGaw Avenue ; IRVINE, CA 92614 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
Clinpro Tooth Creme 3M ESPE Dental Products, Sheffield Pharmaceuticals LLC	Otc Medication	2024-08-08
PerioMed 3M ESPE Dental Products	Otc Medication	2024-08-08
Peridex 3M ESPE Dental Products, Xttrium Laboratories, Inc.	Otc Medication	2024-08-08
Peridex 3M ESPE Dental Products	Prescription Medication	2024-08-08
OMNI 3M ESPE Dental Products	Otc Medication	2024-08-08
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2024-08-07
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2024-08-07
Just For Kids 3M ESPE Dental Products, Dental Technologies, Inc.	Otc Medication	2024-08-07
Clinpro 5000 3M ESPE Dental Products	Prescription Medication	2024-08-06
Clinpro 5000 Solventum US LLC	Prescription Medication	2024-08-06
Clinpro 5000 Solventum US OpCo LLC	Prescription Medication	2024-08-06
Clinpro 5000 3M ESPE Dental Products	Prescription Medication	2024-07-19
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2024-06-06
Clinpro Tooth Creme 3M ESPE Dental Products, Sheffield Pharmaceuticals LLC	Otc Medication	2024-04-03
Just For Kids 3M ESPE Dental Products, Dental Technologies, Inc.	Otc Medication	2024-04-03
PerioMed 3M ESPE Dental Products	Otc Medication	2024-04-02
Peridex 3M ESPE Dental Products, Xttrium Laboratories, Inc.	Otc Medication	2024-04-02
Peridex 3M ESPE Dental Products	Prescription Medication	2024-04-02
Clinpro 5000 3M ESPE Dental Products	Prescription Medication	2024-03-31
Clinpro 5000 Solventum US LLC	Prescription Medication	2024-03-31
Clinpro 5000 Solventum US OpCo LLC	Prescription Medication	2024-03-31
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2024-03-31
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2024-03-31
OMNI 3M ESPE Dental Products	Otc Medication	2024-03-31
Avagard D 3M ESPE Dental Products, Accupac, Inc.	Otc Medication	2024-03-29
Clinpro Tooth Creme 3M ESPE Dental Products, Sheffield Pharmaceuticals LLC	Otc Medication	2023-10-04
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2023-10-04
Peridex 3M ESPE Dental Products, Xttrium Laboratories, Inc.	Otc Medication	2023-04-06
Peridex 3M ESPE Dental Products	Prescription Medication	2023-04-01
PerioMed 3M ESPE Dental Products	Otc Medication	2022-07-27
Peridex 3M ESPE Dental Products	Prescription Medication	2022-07-26
Clinpro 5000 Solventum US LLC	Prescription Medication	2022-07-22
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2022-02-03
Clinpro 5000 3M ESPE Dental Products	Prescription Medication	2021-12-02
Clinpro 5000 Solventum US LLC	Prescription Medication	2021-12-02
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2021-12-02
Avagard D 3M ESPE Dental Products, Accupac, Inc.	Otc Medication	2021-12-02
Clinpro 5000 3M ESPE Dental Products	Prescription Medication	2021-07-09
Peridex 3M ESPE Dental Products, Xttrium Laboratories, Inc.	Otc Medication	2020-10-13
Clinpro Tooth Creme 3M ESPE Dental Products, Sheffield Pharmaceuticals LLC	Otc Medication	2020-07-10
PerioMed 3M ESPE Dental Products	Otc Medication	2020-07-10
Peridex 3M ESPE Dental Products	Prescription Medication	2020-07-10
Clinpro 5000 Solventum US OpCo LLC	Prescription Medication	2020-07-09
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2020-07-09
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2020-07-09
Peridex 3M ESPE Dental Products, Xttrium Laboratories, Inc.	Otc Medication	2020-07-09
OMNI 3M ESPE Dental Products	Otc Medication	2020-07-09
Clinpro 5000 3M ESPE Dental Products	Prescription Medication	2020-07-03
Avagard D 3M ESPE Dental Products, Accupac, Inc.	Otc Medication	2020-04-29
Avagard D 3M ESPE Dental Products, Accupac, Inc.	Otc Medication	2020-04-23
Avagard D 3M ESPE Dental Products, Accupac, Inc.	Otc Medication	2020-02-26
Peridex 3M ESPE Dental Products, Xttrium Laboratories, Inc.	Otc Medication	2020-01-23
Clinpro Tooth Creme 3M ESPE Dental Products, Sheffield Pharmaceuticals LLC	Otc Medication	2020-01-22
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2020-01-22
Clinpro 5000 Solventum US OpCo LLC	Prescription Medication	2019-06-14
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2019-06-14
PerioMed 3M ESPE Dental Products	Otc Medication	2019-06-13
Peridex 3M ESPE Dental Products	Prescription Medication	2019-06-13
Just For Kids 3M ESPE Dental Products, Dental Technologies, Inc.	Otc Medication	2019-06-13
OMNI 3M ESPE Dental Products	Otc Medication	2019-06-13
PMN K191122 3M ESPE Dental Products	3M RelyX Pediatric Resin Modified Glass Ionomer Cement	2019-05-29
Clinpro Tooth Creme 3M ESPE Dental Products, Sheffield Pharmaceuticals LLC	Otc Medication	2019-05-14
Avagard D 3M ESPE Dental Products, Accupac, Inc.	Otc Medication	2019-01-25
PMN K183476 3M ESPE Dental Products	3M Filtek Universal Restorative	2019-01-02
Peridex 3M ESPE Dental Products, Xttrium Laboratories, Inc.	Otc Medication	2017-06-29
Clinpro Tooth Creme 3M ESPE Dental Products	Otc Medication	2017-06-23
PMN K141081 3M ESPE DENTAL PRODUCTS	FILTEK BULK FILL POSTERIOR RESTROATIVE	2014-05-08
NDC 48878-3150 3M ESPE Dental Products	Clinpro Tooth Creme	2013-07-18
Skin antisepsis, oral cleansing, nasal antisepsis Sage Products, Inc., 3M ESPE Dental Products, 3M Health Care LTD	Otc Medication	2012-10-26
PMN K094064 | LLZ 3M ESPE DENTAL PRODUCTS [3M COMPANY]	ILUMAVision, v. 2.2	2012-08-30
PMN K120453 3M ESPE DENTAL PRODUCTS	FILTEK BULK FILL FLOWABLE RESTORATIVE	2012-03-19
OUG 3M ESPE DENTAL PRODUCTS [3M COMPANY]	3M?	2011-12-16
OUG 3M ESPE DENTAL PRODUCTS [3M COMPANY]	3M	2011-12-16
PMN K111185 3M ESPE DENTAL PRODUCTS	RELYX LUTING PLUS AUTOMIX	2011-05-05
PMN K110131 3M ESPE DENTAL PRODUCTS	LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE	2011-01-21
NDC 48878-3140 3M ESPE Dental Products	Clinpro 5000	2011-01-07
PMN K101528 | JOJ 3M ESPE Dental Products [3M COMPANY]	3M Comply	2010-12-16
PMN K101528 | JOJ 3M ESPE DENTAL PRODUCTS [3M COMPANY]	3M Comply	2010-12-16
NDC 48878-3130 3M ESPE Dental Products	Clinpro 5000	2010-10-15
PMN K092141 3M ESPE DENTAL PRODUCTS	VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH	2010-03-10
NDC 48878-3120 3M ESPE Dental Products	Clinpro 5000	2009-01-01
PMN K073697 | DYH 3M ESPE Dental Products [3M COMPANY]	Transbond Supreme Low Viscosity Adh	2008-04-21
PMN K073697 | DYH 3M ESPE Dental Products [3M COMPANY]	Transbond Supreme LV Light Cure Adhesive	2008-04-21
PMN K073697 | DYH 3M ESPE Dental Products [3M COMPANY]	Transbond Supreme LV Adhesive,	2008-04-21
PMN K073697 | DYH 3M ESPE Dental Products [3M COMPANY]	Transbond Supreme Adhesive,	2008-04-21
PMN K073395 3M ESPE DENTAL PRODUCTS	GILB-2, GLASS IONOMER PROTECTIVE COATING	2008-01-17
PMN K940707 | FXX 3M ESPE DENTAL PRODUCTS [3M COMPANY]	3M Tie-On Surgical Mask	2007-12-11
PMN K910182 | FXX 3M ESPE DENTAL PRODUCTS [3M COMPANY]	3M Surgical Masks	2007-12-07
PMN K950514 | DYH 3M ESPE Dental Products [3M COMPANY]	Unitek Multi-Cure Glass Ionomer Orthodontic Band Cement	2007-11-27
PMN K911271 | DYH 3M ESPE Dental Products [3M COMPANY]	APC II	2007-11-27
PMN K880393 | DYH 3M ESPE Dental Products [3M COMPANY]	Transbond XT	2007-11-27
PMN K880393 | DYH 3M ESPE Dental Products [3M COMPANY]	Transbond LR	2007-11-27
PMN K020394 | EJF 3M ESPE Dental Products [3M COMPANY]	Transbond PLUS Color Change	2007-11-27
PMN K020394 | EJF 3M ESPE Dental Products [3M COMPANY]	APC PLUS	2007-11-27
PMN K020394 | DYW 3M ESPE Dental Products [3M COMPANY]	Transbond PLUS Color Change	2007-11-27
PMN K020394 | DYW 3M ESPE Dental Products [3M COMPANY]	APC PLUS	2007-11-27
PMN K020394 | DYH 3M ESPE Dental Products [3M COMPANY]	Transbond PLUS Color Change	2007-11-27
PMN K020394 | DYH 3M ESPE Dental Products [3M COMPANY]	APC PLUS	2007-11-27
DYH 3M ESPE Dental Products [3M COMPANY]	Sondhi Rapid-Set Indirect Bonding Adhesive	2007-11-27
DYH 3M ESPE Dental Products [3M COMPANY]	Concise Orthodontic Bonding System	2007-11-27
PMN K070956 3M ESPE DENTAL PRODUCTS	SEA2 SELF ETCH ADHESIVE	2007-05-22
PMN K062292 3M ESPE DENTAL PRODUCTS	UNICEM	2006-10-25
EJL 3M ESPE Dental Products [3M COMPANY]	Burs	2003-11-26
EJL 3M ESPE Dental Products [3M COMPANY]	Bond Pak	2003-11-26
ELZ 3M ESPE Dental Products [3M COMPANY]	CROWN	2001-08-06
ELZ 3M ESPE DENTAL PRODUCTS [3M COMPANY]	CROWN	2001-08-06
DZN 3M ESPE Dental Products [3M COMPANY]	3M BRAND MATRIX TAPE	2001-08-06
DZN 3M ESPE DENTAL PRODUCTS [3M COMPANY]	3M BRAND MATRIX TAPE	2001-08-06
EHJ 3M ESPE Dental Products [3M COMPANY]	DISK	2001-06-12
EHJ 3M ESPE Dental Products [3M COMPANY]	ABRASIVE	2001-06-12
EHJ 3M ESPE DENTAL PRODUCTS [3M COMPANY]	DISK	2001-06-12
EHJ 3M ESPE DENTAL PRODUCTS [3M COMPANY]	ABRASIVE	2001-06-12
KXR 3M ESPE Dental Products [3M COMPANY]	Standard Applicators	2001-02-26
KXR 3M ESPE Dental Products [3M COMPANY]	RESIN	2001-02-26
KXR 3M ESPE Dental Products [3M COMPANY]	Mixing Wells	2001-02-26
KXR 3M ESPE Dental Products [3M COMPANY]	Disposable Mini Sponge Applicators	2001-02-26
KXR 3M ESPE Dental Products [3M COMPANY]	Brush Tips	2001-02-26
KXR 3M ESPE Dental Products [3M COMPANY]	Brush Holder	2001-02-26
KXR 3M ESPE DENTAL PRODUCTS [3M COMPANY]	Standard Applicators	2001-02-26
KXR 3M ESPE DENTAL PRODUCTS [3M COMPANY]	RESIN	2001-02-26
KXR 3M ESPE DENTAL PRODUCTS [3M COMPANY]	Mixing Wells	2001-02-26
KXR 3M ESPE DENTAL PRODUCTS [3M COMPANY]	Disposable Mini Sponge Applicators	2001-02-26
KXR 3M ESPE DENTAL PRODUCTS [3M COMPANY]	Brush Tips	2001-02-26
KXR 3M ESPE DENTAL PRODUCTS [3M COMPANY]	Brush Holder	2001-02-26
NDC 48878-0231 3M ESPE Dental Products	Avagard D	1999-10-01
NDC 48878-4061 3M ESPE Dental Products	OMNI	1998-02-01
NDC 48878-4070 3M ESPE Dental Products	Just For Kids	1997-07-01
NDC 48878-4020 3M ESPE Dental Products	Just For Kids	1997-07-01
JTQ 3M ESPE DENTAL PRODUCTS [3M COMPANY]	3M Attest Biological Incubator	1995-03-02
ECO 3M ESPE Dental Products [3M COMPANY]	Unitek TAD Constant Force Coil Springs	1992-12-03
ECO 3M ESPE Dental Products [3M COMPANY]	Unitek Orthodontic Springs	1992-12-03
ECO 3M ESPE Dental Products [3M COMPANY]	Hi-T II Coil Springs	1992-12-03
ECO 3M ESPE Dental Products [3M COMPANY]	Forsus Fatigue Resistant Device	1992-12-03
NDC 48878-0620 3M ESPE Dental Products	Peridex	1986-08-13
NDC 48878-3317 3M ESPE Dental Products	PerioMed	1967-07-01
NDC 48878-3315 3M ESPE Dental Products	PerioMed	1967-07-01

Similar & Related FDA Registered Companies

• 3M ESPE AG DENTAL PRODUCTS
• Sheffield Pharmaceuticals LLC
• Xttrium Laboratories, Inc.
• Dental Technologies, Inc.
• Solventum US OpCo LLC
• Solventum US LLC
• Accupac, Inc.
• Sage Products, Inc.
• 3M Health Care LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020051510991	Anvers,Belgium -> Long Beach, California	AS 050-01-09-6XASET-S,50ML,1:1,PP WHITE/TEAL	36 CTN