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Pulpdent Corporation

United States·US-MF-000004897

Last updated September 17, 2026

About

Pulpdent is a dental product research, sales, and manufacturing company located in Watertown, Massachusetts, USA.

From the manufacturer's own website. Source

Information

Country: United States
Address: 80, Oakland Street, Watertown, United States
Website: www.pulpdent.com
LinkedIn: linkedin.com/company/pulpdent-corporation
Facebook: facebook.com/pulpdentfr
Email: [email protected]
Phone: +1 617 926 6666
PRRC Contact: Marjorie Cote
EUDAMED SRN: US-MF-000004897
FDA FEI Number: 1215305
DUNS Number: —

Catalogue (478)

Page 6 of 10

Device	Model / Reference	Registries	Class	Status
ACTIVA™ Kids BioACTIVE Bulk Flow	VKBF1OW	FDA UDI	Class II	Active
EMBRACE VARNISH Sample	SFV	FDA UDI	Class II	Active
ETCH-ALL™ Dental Etching Gel	EA5	FDA UDI	Class II	Active
Activa Cement Translucent	SVCT	FDA UDI	Class II	Active
Code Rings	CR1-50	FDA UDI	Class I	Active
Tuff-Temp Plus	TTP5B1	FDA UDI	Class II	Active
Code Rings	CR5-50	FDA UDI	Class I	Active
GlassLine™ Kit	ILI	FDA UDI	Class II	Active
Tuff-Temp Plus	TTPA210	FDA UDI	Class II	Active
File-Rite™	FILE	FDA UDI	Class I	Active
Tuff-Temp Plus	TTP5A35	FDA UDI	Class II	Active
Ortho-Choice™	OCGI	FDA UDI	Class II	Active
Applicators	APRC20, B580002	EUDAMED	Class I	Active
T-Bands	BTBCW	EUDAMEDFDA UDI	Class I	Active
Applicators	PSN-22	EUDAMEDFDA UDI	Class I	Active
Kool-Dam	ESFD, 5028289L0	EUDAMED	Class I	Active
Applicators	ACEM20, F670002	EUDAMED	Class I	Active
Core Forms	HCF-4	EUDAMEDFDA UDI	Class I	Active
T-Bands	BTSS/A	EUDAMEDFDA UDI	Class I	Active
Applicators	AD50T	EUDAMEDFDA UDI	Class I	Active
Wedges	W	EUDAMEDFDA UDI	Class I	Active
Flecta Disposable Mirrors	FLEC	EUDAMEDFDA UDI	Class I	Active
T-Bands	BTSS/N	EUDAMEDFDA UDI	Class I	Active
Applicators	PSN-22A	EUDAMEDFDA UDI	Class I	Active
Core Forms	HCFAP, F80690	EUDAMED	Class I	Active
Applicators	30F100	EUDAMEDFDA UDI	Class I	Active
T-Bands	BTSS/W	EUDAMEDFDA UDI	Class I	Active
Applicators	TE50N	EUDAMEDFDA UDI	Class I	Active
Applicators	AS20	EUDAMEDFDA UDI	Class I	Active
Syringes, oral, empty refill	SY-ER3	EUDAMEDFDA UDI	Class I	Active
Dispensers	DS50	EUDAMEDFDA UDI	Class I	Active
Triple-Cure Paste/Paste Resin-Reinforced Glass Ionomer Cement	K030036	FDA 510(k)	Class II	Active
Root Canal Sealer, Modified Grossmans' Formula	K896657	FDA 510(k)	Class II	Active
Pulpdent Cavity Preparation Iv	K013411	FDA 510(k)	Class II	Active
Pulpdent Semi-Gel Etch	K022492	FDA 510(k)	Class II	Active
Pulpdent Dentastic Ii	K953272	FDA 510(k)	Class II	Active
Pulpdent Uno-Duo	K993683	FDA 510(k)	Class II	Active
4% Acidulated Phosphate Fluoride Etching Gel	K920460	FDA 510(k)	Class II	Active
Pulpdent Putty Dam	K022522	FDA 510(k)	Class I	Active
Pulpdent Cavity Preparation 1, Pulpdent Cavity Preparation 1 With Fluoride	K994182	FDA 510(k)	Class II	Active
Embrace Wetbond Restoration And Pfm Repair Kit	K032953	FDA 510(k)	Class II	Active
Embrace Wet-Bond Restorative Material	K031877	FDA 510(k)	Class II	Active
Mirror Shield	K901053	FDA 510(k)	Class I	Active
Pulpdent Periodontal Dressings	K946137	FDA 510(k)	Class II	Active
Pulpdent Solo Flowable Composite with MCP	K153249	FDA 510(k)	Class II	Active
Pulpdent Micro-Hybrid Composite	K090391	FDA 510(k)	Class II	Active
Pulpdent Resilute Ii	K962383	FDA 510(k)	Class II	Active
Pulpdent Sealant/Paste Orthodontic Bracket Adhesive System	K020115	FDA 510(k)	Class II	Active
Ken's Prophy Gel - Regular	K896661	FDA 510(k)	Class I	Active
Pulpdent Cavity Preparation Iii	K994180	FDA 510(k)	Class II	Active

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